Skip to content

Biostar Oia Shigatox

by Inverness Medical-Biostar, Inc.

510(k) K061889

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061889 Date12 Dec 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0965-2017 FDA Class II initiated 27 Sep 2016 on shared 510(k) K061889

    Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

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  • Withdrawn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
GMZ
Device Class
Class I
Regulation
21 CFR Part 866.3255
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent