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Gyrus Acmi Bicoag Hemostasis Probe

by Olympus Surgical Technologies America

510(k) K123319

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 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 · Special NumberK123319 Date14 Dec 2012ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-3246-2026 FDA Class II initiated 19 Aug 2026
    • Ongoing Z-3244-2026 FDA Class II initiated 19 Aug 2026
    • Ongoing Z-3247-2026 FDA Class II initiated 19 Aug 2026
    • Ongoing Z-3245-2026 FDA Class II initiated 19 Aug 2026

    Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

    • Ongoing Z-1481-2024 FDA Class II initiated 5 Jan 2024

    The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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