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Tur, Arthroscopic, Cystoscopy Irrigation Sets

by Baxter Healthcare Corp

510(k) K960787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK960787 Date14 May 1996ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1010-2015 FDA Class II initiated 14 Jan 2015 on shared 510(k) K960787

    Potential for failure of the pouch packaging seal at high altitudes.

  • 3 recalls, same reason

    • Terminated Z-1683-2013 FDA Class II initiated 15 May 2013
    • Terminated Z-1684-2013 FDA Class II initiated 15 May 2013
    • Terminated Z-1682-2013 FDA Class II initiated 15 May 2013

    A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

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  • Withdrawn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
LJH
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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