Skip to content

SINGLE USE PRELOADED SPHINCTEROTOME V - Single Use Sp

by Olympus Medical Systems Copr.

510(k) K141991

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141991 Date31 Mar 2015ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1279-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1297-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1278-2026 FDA Class II initiated 7 Jan 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Models / Variants
Single Use Sp
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent