{ "code": "GEI", "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories", "deviceClass": "II", "regulationNumber": "878.4400", "panel": "General, Plastic Surgery", "definition": "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 2312, "last12Months": 59 }, "adverseEvents": { "total": 22525, "last12Months": 4957 }, "reviewDays": { "median": 83, "sampleSize": 2312 }, "recalls": { "total": 643, "recent": [ { "resNumber": "Z-2865-2026", "status": "Open, Classified", "recallClass": null, "firm": "Stryker Corporation", "firmAsPublished": "Stryker Corporation", "reason": "There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.", "initiated": "2026-06-08" }, { "resNumber": "Z-2866-2026", "status": "Open, Classified", "recallClass": null, "firm": "Stryker Corporation", "firmAsPublished": "Stryker Corporation", "reason": "There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.", "initiated": "2026-06-08" }, { "resNumber": "Z-2741-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Maquet Cardiovascular, LLC", "firmAsPublished": "Maquet Cardiovascular, LLC", "reason": "Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.", "initiated": "2026-06-02" }, { "resNumber": "Z-1851-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Olympus Corporation of the Americas", "firmAsPublished": "Olympus Corporation of the Americas", "reason": "Potential for detachment of a distal tip component of the device during use.", "initiated": "2026-03-23" }, { "resNumber": "Z-1852-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Olympus Corporation of the Americas", "firmAsPublished": "Olympus Corporation of the Americas", "reason": "Potential for detachment of a distal tip component of the device during use.", "initiated": "2026-03-23" } ] }, "recentClearances": [ { "kNumber": "K261179", "deviceName": "AlphaTriPart - Monopolar MIC Instruments", "applicant": "Gimmi GmbH", "company": "Gimmi GmbH", "decisionDate": "2026-07-22", "dateReceived": "2026-04-10" }, { "kNumber": "K253504", "deviceName": "Volnewmer™", "applicant": "Classys, Inc.", "company": "Classys, Inc.", "decisionDate": "2026-07-13", "dateReceived": "2025-10-31" }, { "kNumber": "K254056", "deviceName": "THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)", "applicant": "Olympus Medical Systems Corp.", "company": "Olympus Medical Systems Corporation", "decisionDate": "2026-07-01", "dateReceived": "2025-12-17" }, { "kNumber": "K253484", "deviceName": "LUTRONIC GENIUS", "applicant": "Cynosure Lutronic Technology Corporation", "company": "Cynosure Lutronic Technology Corporation", "decisionDate": "2026-06-29", "dateReceived": "2025-10-17" }, { "kNumber": "K251492", "deviceName": "Irrigation Tubing Bipolar Cord Set", "applicant": "New Deantronics Taiwan , Ltd.", "company": "New Deantronics Taiwan , Ltd.", "decisionDate": "2026-06-29", "dateReceived": "2025-05-15" }, { "kNumber": "K260636", "deviceName": "Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating", "applicant": "Stryker Sustainability Solutions", "company": "Stryker Sustainability Solutions", "decisionDate": "2026-06-18", "dateReceived": "2026-02-26" }, { "kNumber": "K253634", "deviceName": "CoolSeal Generator® (CSL-200-90)", "applicant": "Hologic, Inc.", "company": "Hologic, Inc.", "decisionDate": "2026-06-17", "dateReceived": "2025-11-19" }, { "kNumber": "K261833", "deviceName": "NEUROMARK System (NMK00301)", "applicant": "Neurent Medical , Ltd.", "company": "NEURENT MEDICAL LIMITED", "decisionDate": "2026-06-16", "dateReceived": "2026-06-02" }, { "kNumber": "K253165", "deviceName": "LAP-iX2N", "applicant": "Sejong Medical Co., Ltd.", "company": "Sejong Medical Co., Ltd.", "decisionDate": "2026-06-09", "dateReceived": "2025-09-26" }, { "kNumber": "K253656", "deviceName": "OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System", "applicant": "Medtronic Sofamor Danek USA, Inc.", "company": "Medtronic Sofamor Danek USA, Inc", "decisionDate": "2026-06-05", "dateReceived": "2025-11-20" } ], "topApplicants": [ { "name": "Arthrocare Corp.", "count": 64 }, { "name": "Valleylab, Inc.", "count": 60 }, { "name": "Conmedcorp", "count": 43 }, { "name": "Megadyne Medical Products, Inc.", "count": 32 }, { "name": "Aaron Medical Industries", "count": 27 } ], "topCompanies": [ { "name": "ArthroCare Corporation", "count": 86, "spellings": 2 }, { "name": "Valleylab,A Division of Tyco Healthcare Group LP", "count": 71, "spellings": 3 }, { "name": "Conmedcorp", "count": 43, "spellings": 1 }, { "name": "Covidien", "count": 40, "spellings": 3 }, { "name": "Megadyne Medical Products, Inc.", "count": 32, "spellings": 1 } ], "newEntrants": [ { "name": "Gimmi GmbH", "since": "2026-07-22", "kNumber": "K261179" }, { "name": "Cynosure Lutronic Technology Corporation", "since": "2026-06-29", "kNumber": "K253484" }, { "name": "Hologic, Inc.", "since": "2026-06-17", "kNumber": "K253634" }, { "name": "Lumenis Be, Inc.", "since": "2026-06-02", "kNumber": "K253803" }, { "name": "Lagis Enterprise Co., Ltd.", "since": "2026-05-20", "kNumber": "K253134" }, { "name": "Ascblue Corporation", "since": "2026-04-10", "kNumber": "K253777" }, { "name": "Zhejiang shuyou Surgical Instrument Co., Ltd.", "since": "2026-04-07", "kNumber": "K260466" }, { "name": "Prana Surgical", "since": "2026-04-01", "kNumber": "K253405" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 592, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 543, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 625, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 511, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 616, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 597, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 510, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 545, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 527, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 767, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 653, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 777, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 739, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 706, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 624, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 666, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 613, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 623, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 631, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 537, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 562, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 536, "expectedLow": 347.04819508089446, "expectedHigh": 743.8588193189335, "isSufficient": true }, { "month": "2025-02-01", "observed": 472, "expectedLow": 306.20115544303394, "expectedHigh": 636.6573220334656, "isSufficient": true }, { "month": "2025-03-01", "observed": 563, "expectedLow": 342.7693916237662, "expectedHigh": 716.5204797010181, "isSufficient": true }, { "month": "2025-04-01", "observed": 679, "expectedLow": 405.58908063146976, "expectedHigh": 708.9932309661971, "isSufficient": true }, { "month": "2025-05-01", "observed": 533, "expectedLow": 441.24014111289233, "expectedHigh": 670.1578283704059, "isSufficient": true }, { "month": "2025-06-01", "observed": 693, "expectedLow": 463.16895216719263, "expectedHigh": 674.7717855655915, "isSufficient": true }, { "month": "2025-07-01", "observed": 695, "expectedLow": 758.1047445730641, "expectedHigh": 1145.054625037882, "isSufficient": true }, { "month": "2025-08-01", "observed": 618, "expectedLow": 494.1625631581174, "expectedHigh": 826.5151727112319, "isSufficient": true }, { "month": "2025-09-01", "observed": 621, "expectedLow": 506.36600389943857, "expectedHigh": 857.8393261742432, "isSufficient": true }, { "month": "2025-10-01", "observed": 700, "expectedLow": 481.4581591826333, "expectedHigh": 836.2500398863803, "isSufficient": true }, { "month": "2025-11-01", "observed": 572, "expectedLow": 443.84398231671986, "expectedHigh": 764.5099593472411, "isSufficient": true }, { "month": "2025-12-01", "observed": 743, "expectedLow": 484.83599061074597, "expectedHigh": 833.0016625958408, "isSufficient": true }, { "month": "2026-01-01", "observed": 526, "expectedLow": 591.1752006252492, "expectedHigh": 988.8724493703742, "isSufficient": true }, { "month": "2026-02-01", "observed": 652, "expectedLow": 388.187905223031, "expectedHigh": 814.5985328595392, "isSufficient": true }, { "month": "2026-03-01", "observed": 702, "expectedLow": 443.0181611762302, "expectedHigh": 910.1762651749088, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "GEI (Electrosurgical, Cutting & Coagulation & Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2865-2026, Z-2866-2026, Z-2741-2026, Z-1851-2026, Z-1852-2026). 16 first-time filers in the last 12 months, including Gimmi GmbH and Cynosure Lutronic Technology Corporation (K261179, K253484, K253634, K253803, K253134). Clearances are running 63% slower — a median 135 days over the last 12 months against 83 days all-time (elapsed calendar days, not FDA review days) (GEI:review_time:12m). The code is crowded, scoring 100 of 100 — 697 companies hold a clearance here and 59 arrived in the last 12 months (GEI:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2865-2026", "Z-2866-2026", "Z-2741-2026", "Z-1851-2026", "Z-1852-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "16 first-time filers in the last 12 months, including Gimmi GmbH and Cynosure Lutronic Technology Corporation", "recordIds": [ "K261179", "K253484", "K253634", "K253803", "K253134" ], "severity": 50 }, { "kind": "review_time_shift", "detail": "clearances are running 63% slower — a median 135 days over the last 12 months against 83 days all-time (elapsed calendar days, not FDA review days)", "recordIds": [ "GEI:review_time:12m" ], "severity": 30 }, { "kind": "crowding", "detail": "the code is crowded, scoring 100 of 100 — 697 companies hold a clearance here and 59 arrived in the last 12 months", "recordIds": [ "GEI: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%3AGEI" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEI" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEI" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGEI" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGEI" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGEI" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGEI" } ], "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": "2026-08-11T13:51:45.702Z" }