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Olympus B-5/B-7 Seriesballoon Catheter

by Olympus America, Inc.

510(k) K962925

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK962925 Date25 Oct 1996ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0961-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0964-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0963-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0965-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0962-2021 FDA Class II initiated 4 Jan 2021

    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.

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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