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Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

FDA product code KNS · Class 2 · Gastroenterology, Urology

1,186
Registered devices
17,612
Adverse events
125
Recalls
189
510(k) clearances

Devices with this code

Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.Mini-Tome — COOK INCORPORATEDGuenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHNA — Hangzhou AGS MedTech Co., Ltd.Single Use Balloon Dilator V (with Knife) — OLYMPUS MEDICAL SYSTEMS CORP.Injection Gold Probe — BOSTON SCIENTIFIC CORPORATIONTruPass, FX Wire — Conmed CorporationSingle Use Preloaded Sphincterotome V (Distal Wireguided) — OLYMPUS MEDICAL SYSTEMS CORP.Torrent — US EndoscopyUltrasonic Generator — OLYMPUS MEDICAL SYSTEMS CORP.OPTIMIZER — Conmed CorporationNA — Richard Wolf GmbHGyrus ACMI — Gyrus ACMI, LLCGuenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHSingle Use 2-Lumen Sphincterotome V — OLYMPUS MEDICAL SYSTEMS CORP.CROMA Electrosurgical Generator — CREO MEDICAL LIMITEDVanquish Water Vapor Ablation System — Francis Medical, Inc.Single Use Preloaded Sphincterotome V — OLYMPUS MEDICAL SYSTEMS CORP.ZKSK — Beijing ZKSK Technology Co.,LtdSingle Use 3-Lumen Sphincterotome V — OLYMPUS MEDICAL SYSTEMS CORP.ELECTROSURGICAL SNARE — OLYMPUS MEDICAL SYSTEMS CORP.Single Use Preloaded Sphincterotome V(Distal Wireguided) — OLYMPUS MEDICAL SYSTEMS CORP.Redfield IRC 2100 — Coopersurgical, Inc.DISPOSABLE PAPILLOTOMY KNIFE — OLYMPUS MEDICAL SYSTEMS CORP.

Recent recalls

DateFirmReason
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.