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Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215

by Olympus Medical Systems Corporation GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170371158 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1282-2026 FDA Class II initiated 7 Jan 2026

    Devices which did not undergo thermoforming could deform and lose performance.

Specification

GUDID

Trade Name
Single Use Sphincterotome V(Distal Wireguided)
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / Ref / Catalog
KD-VC412Q-0215, N5391430
Primary DI / UDI-DI
04953170371158
510(k) Number
FDA Product Code
KNS
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K160241)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No