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Iumc Endometrial Sampler

by Cook Ob/Gyn

510(k) K941298

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 NumberK941298 Date13 Feb 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1416-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009

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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  • Withdrawn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
HFE
Device Class
Class II
Regulation
21 CFR Part 884.1100
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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