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Gift Catheter Set/S

by Cook Ob/Gyn

510(k) K983590

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983590 Date21 Dec 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1187-2018 FDA Class II initiated 19 Dec 2017

    Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.

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  • Withdrawn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
MQF
Device Class
Class II
Regulation
21 CFR Part 884.6110
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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