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Electrosurgical, Cutting & Coagulation & Accessories
FDA product code GEI · Class 2 · General, Plastic Surgery
51,276
Registered devices
119,015
Adverse events
644
Recalls
2,319
510(k) clearances
Devices with this code
Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Kirwan — KIRWAN SURGICAL PRODUCTS LLCKirwan — KIRWAN SURGICAL PRODUCTS LLCSymmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.AESCULAP — AESCULAP, INC.DANmed — DANNORITZER Medizintechnik GmbH & Co. KGnxt™ Bipolar Forceps — adeor Medical AGnxt™ Bipolar Forceps — adeor Medical AGVictan — Jiangsu Haize Medical Scientific Development Co.,Ltd.Spetzler-Malis — STRYKER CORPORATIONAEM® Disposable Handswitching Handpiece with Rocker Switch — ENCISION, INC.Surgical Direct — Surgical Direct, Inc.Kirwan — KIRWAN SURGICAL PRODUCTS LLCKirwan — KIRWAN SURGICAL PRODUCTS LLCSymmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE — HEMOSTATIX MEDICAL TECHNOLOGIES LLCAESCULAP — Aesculap AGERAGON MODULAR — Richard Wolf GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Olympus Corporation of the Americas | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-02 | Maquet Cardiovascular, LLC | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization r |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul |
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