{ "code": "GDW", "deviceName": "Staple, Implantable", "deviceClass": "II", "regulationNumber": "878.4750", "panel": "General, Plastic Surgery", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 283, "last12Months": 3 }, "adverseEvents": { "total": 38913, "last12Months": 7515 }, "reviewDays": { "median": 71, "sampleSize": 283 }, "recalls": { "total": 225, "recent": [ { "resNumber": "Z-0485-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Covidien", "firmAsPublished": "Covidien, LP", "reason": "A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.", "initiated": "2025-09-25" }, { "resNumber": "Z-0486-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Covidien", "firmAsPublished": "Covidien, LP", "reason": "A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.", "initiated": "2025-09-25" }, { "resNumber": "Z-0147-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Ethicon Endo Surgery, LLC", "firmAsPublished": "Ethicon Endo-Surgery Inc", "reason": "The devices were shipped unsterilized.", "initiated": "2025-09-11" }, { "resNumber": "Z-1746-2025", "status": "Open, Classified", "recallClass": "Class I", "firm": "Ethicon Endo Surgery, LLC", "firmAsPublished": "Ethicon Endo-Surgery Inc", "reason": "Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.", "initiated": "2025-04-22" }, { "resNumber": "Z-3096-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Smith & Nephew, Inc.", "firmAsPublished": "Smith & Nephew Inc.", "reason": "Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility", "initiated": "2024-08-12" } ] }, "recentClearances": [ { "kNumber": "K260196", "deviceName": "ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)", "applicant": "Ethicon Endo-Surgery, LLC", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2026-05-11", "dateReceived": "2026-01-22" }, { "kNumber": "K253657", "deviceName": "Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads", "applicant": "Covidien (Part of Medtronic)", "company": "Covidien (Part of Medtronic)", "decisionDate": "2026-04-10", "dateReceived": "2025-11-20" }, { "kNumber": "K252739", "deviceName": "ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)", "applicant": "Ethicon Endo-Surgery, LLC", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2025-12-17", "dateReceived": "2025-08-28" }, { "kNumber": "K250835", "deviceName": "ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)", "applicant": "Ethicon Endo-Surgery, LLC", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2025-05-14", "dateReceived": "2025-03-20" }, { "kNumber": "K243276", "deviceName": "ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)", "applicant": "Ethicon Endo-Surgery, LLC", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2025-02-25", "dateReceived": "2024-10-16" }, { "kNumber": "K241630", "deviceName": "ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)", "applicant": "Ethicon Endo-Surgery, LLC", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2024-10-28", "dateReceived": "2024-06-06" }, { "kNumber": "K242679", "deviceName": "Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)", "applicant": "Fengh Medical Co., Ltd.", "company": "Fengh Medical Co., Ltd.", "decisionDate": "2024-10-04", "dateReceived": "2024-09-06" }, { "kNumber": "K222487", "deviceName": "Anika Tissue Tack Fixation System", "applicant": "Anika Therapeutics, Inc.", "company": "Anika Therapeutics, Inc.", "decisionDate": "2023-05-08", "dateReceived": "2022-08-17" }, { "kNumber": "K222210", "deviceName": "AEON Endoscopic Stapler", "applicant": "Lexington Medical, Inc.", "company": "Lexington Medical, Inc.", "decisionDate": "2023-04-21", "dateReceived": "2022-07-25" }, { "kNumber": "K223760", "deviceName": "ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)", "applicant": "Ethicon Endo-Surgery", "company": "Ethicon Endo Surgery, LLC", "decisionDate": "2023-03-15", "dateReceived": "2022-12-15" } ], "topApplicants": [ { "name": "United States Surgical, A Division of Tyco Healthc", "count": 28 }, { "name": "Ethicon Endo-Surgery, LLC", "count": 27 }, { "name": "Covidien", "count": 22 }, { "name": "Power Medical Interventions, Inc.", "count": 22 }, { "name": "Ethicon Endo-Surgery, Inc.", "count": 16 } ], "topCompanies": [ { "name": "Ethicon Endo Surgery, LLC", "count": 44, "spellings": 3 }, { "name": "United States Surgical, A Division of Tyco Healthc", "count": 28, "spellings": 1 }, { "name": "Covidien", "count": 27, "spellings": 2 }, { "name": "Power Medical Interventions, Inc.", "count": 22, "spellings": 1 }, { "name": "C.R. Bard, Inc.", "count": 10, "spellings": 1 } ], "newEntrants": [ { "name": "Covidien (Part of Medtronic)", "since": "2026-04-10", "kNumber": "K253657" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1021, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1012, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 1416, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1120, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 1227, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1471, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 1152, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 1079, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 1100, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 1335, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 1128, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 951, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 1149, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 1059, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 1126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 1149, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 1086, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1250, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1109, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 1000, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 938, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1011, "expectedLow": 691.2250515498835, "expectedHigh": 1227.5620578451712, "isSufficient": true }, { "month": "2025-02-01", "observed": 782, "expectedLow": 655.0668268010937, "expectedHigh": 1038.8163976228752, "isSufficient": true }, { "month": "2025-03-01", "observed": 828, "expectedLow": 705.6400378310652, "expectedHigh": 1142.1605234581837, "isSufficient": true }, { "month": "2025-04-01", "observed": 993, "expectedLow": 685.3502631613704, "expectedHigh": 1170.790728739077, "isSufficient": true }, { "month": "2025-05-01", "observed": 972, "expectedLow": 684.3831364728785, "expectedHigh": 1088.2560825151354, "isSufficient": true }, { "month": "2025-06-01", "observed": 956, "expectedLow": 737.1015093876186, "expectedHigh": 1159.128091669566, "isSufficient": true }, { "month": "2025-07-01", "observed": 1301, "expectedLow": 1223.3724614988157, "expectedHigh": 1758.037952888329, "isSufficient": true }, { "month": "2025-08-01", "observed": 886, "expectedLow": 867.923107519645, "expectedHigh": 1297.8433357712433, "isSufficient": true }, { "month": "2025-09-01", "observed": 978, "expectedLow": 817.3952830093322, "expectedHigh": 1344.0489561896995, "isSufficient": true }, { "month": "2025-10-01", "observed": 1030, "expectedLow": 826.6180750279585, "expectedHigh": 1252.5712290558029, "isSufficient": true }, { "month": "2025-11-01", "observed": 835, "expectedLow": 741.7589173478688, "expectedHigh": 1125.9113833316771, "isSufficient": true }, { "month": "2025-12-01", "observed": 1063, "expectedLow": 769.1288287551237, "expectedHigh": 1231.911330408525, "isSufficient": true }, { "month": "2026-01-01", "observed": 962, "expectedLow": 915.168733502438, "expectedHigh": 1443.6012265210054, "isSufficient": true }, { "month": "2026-02-01", "observed": 983, "expectedLow": 699.7578270327281, "expectedHigh": 1181.5298605711268, "isSufficient": true }, { "month": "2026-03-01", "observed": 1020, "expectedLow": 781.3171193873849, "expectedHigh": 1307.269743013972, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "GDW (Staple, Implantable) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0485-2026, Z-0486-2026, Z-0147-2026). 1 first-time filer in the last 12 months, Covidien (Part of Medtronic) (K253657). The code is crowded, scoring 69 of 100 — 93 companies hold a clearance here and 3 arrived in the last 12 months (GDW:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-0485-2026", "Z-0486-2026", "Z-0147-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Covidien (Part of Medtronic)", "recordIds": [ "K253657" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 69 of 100 — 93 companies hold a clearance here and 3 arrived in the last 12 months", "recordIds": [ "GDW:crowding" ], "severity": 20 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AGDW" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGDW" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGDW" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGDW" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGDW" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGDW" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGDW" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.701Z" }