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Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

FDA product code KNS · Class 2 · Gastroenterology, Urology

1,005
Registered devices
17,379
Adverse events
121
Recalls
188
510(k) clearances

Devices with this code

Autotome™ Pro RX 44 — BOSTON SCIENTIFIC CORPORATIONAdaptor Cable Bipolar — BOSTON SCIENTIFIC CORPORATIONSingle Use 3-Lumen Sphincterotome V — OLYMPUS MEDICAL SYSTEMS CORP.Sterile Sphincterotome — Micro-Tech (Nanjing) Co., Ltd.ORISE™ ProKnife — BOSTON SCIENTIFIC CORPORATIONSingle Use Sphincterotome V (Distal Wireguided) — OLYMPUS MEDICAL SYSTEMS CORP.Quicksilver — COOK INCORPORATEDSingle Use Preloaded Sphincterotome V(Distal Wireguided) — OLYMPUS MEDICAL SYSTEMS CORP.Ultratome RX — BOSTON SCIENTIFIC CORPORATIONSingle Use Preloaded Sphincterotome V(Distal Wireguided) — OLYMPUS MEDICAL SYSTEMS CORP.Single Plug Bipolar Hemostasis Probe, 7Fr — Merit Medical Systems, Inc.ELECTROSURGICAL KNIFE — OLYMPUS MEDICAL SYSTEMS CORP.NA — Richard Wolf GmbHGuenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHTeslatome — COOK INCORPORATEDSphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHSINGULAR — Conmed CorporationTRUEtome 44 — BOSTON SCIENTIFIC CORPORATIONSphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.Single Use Electrosurgical Knife KD-645 — OLYMPUS MEDICAL SYSTEMS CORP.Cook — COOK INCORPORATEDPolypectomy Snare, Oval - Extra Large — ENDO-THERAPEUTICS, INC.Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH

Recent recalls

DateFirmReason
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.
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.