{ "code": "FGE", "deviceName": "Stents, Drains And Dilators For The Biliary Ducts", "deviceClass": "II", "regulationNumber": "876.5010", "panel": "Gastroenterology, Urology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 475, "last12Months": 9 }, "adverseEvents": { "total": 5521, "last12Months": 1265 }, "reviewDays": { "median": 84, "sampleSize": 475 }, "recalls": { "total": 448, "recent": [ { "resNumber": "Z-2626-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Potential sterile breach of the pouches in which devices are packaged.", "initiated": "2026-05-21" }, { "resNumber": "Z-2627-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Potential sterile breach of the pouches in which devices are packaged.", "initiated": "2026-05-21" }, { "resNumber": "Z-2628-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Potential sterile breach of the pouches in which devices are packaged.", "initiated": "2026-05-21" }, { "resNumber": "Z-2629-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Potential sterile breach of the pouches in which devices are packaged.", "initiated": "2026-05-21" }, { "resNumber": "Z-2630-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Potential sterile breach of the pouches in which devices are packaged.", "initiated": "2026-05-21" } ] }, "recentClearances": [ { "kNumber": "K253393", "deviceName": "Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019", "applicant": "Hangzhou AGS MedTech Co., Ltd.", "company": "Hangzhou AGS MedTech Co., Ltd.", "decisionDate": "2026-06-24", "dateReceived": "2025-09-30" }, { "kNumber": "K253832", "deviceName": "Dilation Balloon Catheter", "applicant": "Mirco-Tech (Nanjing) Co., Ltd.", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "decisionDate": "2026-04-24", "dateReceived": "2025-12-01" }, { "kNumber": "K251658", "deviceName": "Endoflux™ Biliary & Pancreatic Stent Sets", "applicant": "Medi-Globe GmbH", "company": "Medi-Globe Corporation", "decisionDate": "2026-04-16", "dateReceived": "2025-05-30" }, { "kNumber": "K253987", "deviceName": "BARE Wireguided Balloon Dilation Catheter (1235)", "applicant": "GIE Medical", "company": "GIE Medical", "decisionDate": "2026-03-13", "dateReceived": "2025-12-12" }, { "kNumber": "K253132", "deviceName": "Single use stone retrieval balloons", "applicant": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "decisionDate": "2026-03-06", "dateReceived": "2025-09-25" }, { "kNumber": "K251123", "deviceName": "Niti-S Biliary Stent; Niti-S Biliary Slim M Stent", "applicant": "Taewoong Medical Co., Ltd.", "company": "Taewoong Medical Co., Ltd.", "decisionDate": "2025-12-29", "dateReceived": "2025-04-11" }, { "kNumber": "K251019", "deviceName": "BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G", "applicant": "Bioteque Corporation", "company": "Bioteque Corporation", "decisionDate": "2025-12-22", "dateReceived": "2025-04-02" }, { "kNumber": "K250409", "deviceName": "Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)", "applicant": "Olympus Medical Systems Corporation", "company": "Olympus Medical Systems Corporation", "decisionDate": "2025-10-21", "dateReceived": "2025-02-13" }, { "kNumber": "K251229", "deviceName": "EndoFix™Tissue Fixation System", "applicant": "Softac Medical Technologies", "company": "Softac Medical Technologies", "decisionDate": "2025-08-20", "dateReceived": "2025-04-21" }, { "kNumber": "K243412", "deviceName": "ARCHIMEDES Biodegradable Pancreatic Stent", "applicant": "Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)", "company": "Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)", "decisionDate": "2025-07-16", "dateReceived": "2024-11-01" } ], "topApplicants": [ { "name": "Cordis Corp.", "count": 37 }, { "name": "Boston Scientific Corp", "count": 35 }, { "name": "Cook, Inc.", "count": 20 }, { "name": "Wilson-Cook Medical, Inc.", "count": 20 }, { "name": "Guidant Corp.", "count": 17 } ], "topCompanies": [ { "name": "Boston Scientific Corporation", "count": 56, "spellings": 3 }, { "name": "Cordis Corporation", "count": 38, "spellings": 2 }, { "name": "Cook Incorporated", "count": 22, "spellings": 2 }, { "name": "Guidant Corporation", "count": 20, "spellings": 2 }, { "name": "Wilson-Cook Medical Inc.", "count": 20, "spellings": 1 } ], "newEntrants": [ { "name": "Hangzhou AGS MedTech Co., Ltd.", "since": "2026-06-24", "kNumber": "K253393" }, { "name": "Mirco-Tech (Nanjing) Co., Ltd.", "since": "2026-04-24", "kNumber": "K253832" }, { "name": "GIE Medical", "since": "2026-03-13", "kNumber": "K253987" }, { "name": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "since": "2026-03-06", "kNumber": "K253132" }, { "name": "Softac Medical Technologies", "since": "2025-08-20", "kNumber": "K251229" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 116, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 122, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 109, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 160, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 160, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 101, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 159, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 131, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 118, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 116, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 143, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 163, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 164, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 167, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 200, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 163, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 158, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 161, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 180, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 214, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 113, "expectedLow": 117.32469339239412, "expectedHigh": 212.66396456003557, "isSufficient": true }, { "month": "2025-02-01", "observed": 124, "expectedLow": 88.31685956368779, "expectedHigh": 171.9310776958374, "isSufficient": true }, { "month": "2025-03-01", "observed": 157, "expectedLow": 102.77151630962706, "expectedHigh": 185.15124521748652, "isSufficient": true }, { "month": "2025-04-01", "observed": 160, "expectedLow": 110.93401682615531, "expectedHigh": 195.33013613263122, "isSufficient": true }, { "month": "2025-05-01", "observed": 160, "expectedLow": 106.22763241310025, "expectedHigh": 184.54167585056936, "isSufficient": true }, { "month": "2025-06-01", "observed": 157, "expectedLow": 114.2807178206219, "expectedHigh": 196.85123638116963, "isSufficient": true }, { "month": "2025-07-01", "observed": 152, "expectedLow": 182.88606730892855, "expectedHigh": 307.66094595756954, "isSufficient": true }, { "month": "2025-08-01", "observed": 182, "expectedLow": 105.51303758512957, "expectedHigh": 221.93237091516366, "isSufficient": true }, { "month": "2025-09-01", "observed": 162, "expectedLow": 116.76664537033578, "expectedHigh": 239.41867900014708, "isSufficient": true }, { "month": "2025-10-01", "observed": 168, "expectedLow": 109.78414853682338, "expectedHigh": 234.21524501149054, "isSufficient": true }, { "month": "2025-11-01", "observed": 149, "expectedLow": 98.22708044365933, "expectedHigh": 210.46889735522333, "isSufficient": true }, { "month": "2025-12-01", "observed": 190, "expectedLow": 108.41079476679855, "expectedHigh": 230.94980707144603, "isSufficient": true }, { "month": "2026-01-01", "observed": 159, "expectedLow": 141.6360807328186, "expectedHigh": 260.950024040298, "isSufficient": true }, { "month": "2026-02-01", "observed": 124, "expectedLow": 109.68869847426966, "expectedHigh": 210.36627862584604, "isSufficient": true }, { "month": "2026-03-01", "observed": 182, "expectedLow": 101.41185700238641, "expectedHigh": 226.4412755572853, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "FGE (Stents, Drains And Dilators For The Biliary Ducts) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2626-2026, Z-2627-2026, Z-2628-2026, Z-2629-2026, Z-2630-2026). 5 first-time filers in the last 12 months, including Hangzhou AGS MedTech Co., Ltd. and Mirco-Tech (Nanjing) Co., Ltd (K253393, K253832, K253987, K253132, K251229). The code is crowded, scoring 90 of 100 — 131 companies hold a clearance here and 9 arrived in the last 12 months (FGE:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2626-2026", "Z-2627-2026", "Z-2628-2026", "Z-2629-2026", "Z-2630-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "5 first-time filers in the last 12 months, including Hangzhou AGS MedTech Co., Ltd. and Mirco-Tech (Nanjing) Co., Ltd.", "recordIds": [ "K253393", "K253832", "K253987", "K253132", "K251229" ], "severity": 45 }, { "kind": "crowding", "detail": "the code is crowded, scoring 90 of 100 — 131 companies hold a clearance here and 9 arrived in the last 12 months", "recordIds": [ "FGE: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%3AFGE" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFGE" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFGE" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFGE" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFGE" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFGE" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFGE" } ], "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": "2026-08-11T13:51:45.696Z" }