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SINGLE USE 3-LUMEN EXTRACTION BALLOON V - B-V243Q-B

by Olympus Medical Systems Corporation

510(k) K091495

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091495 Date3 Sep 2009ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0967-2021 FDA Class II initiated 4 Jan 2021 on shared 510(k) K091495
    • Terminated Z-0966-2021 FDA Class II initiated 4 Jan 2021 on shared 510(k) K091495
    • Terminated Z-0968-2021 FDA Class II initiated 4 Jan 2021 on shared 510(k) K091495

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LQR
Models / Variants
B-V243Q-B
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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