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Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching

by Cook Ob/Gyn

510(k) K983596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Traditional NumberK983596 Date5 Feb 1999ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2177-2008 FDA Unclassified (pre-2012) initiated 2 Mar 2008
    • Terminated Z-2176-2008 FDA Unclassified (pre-2012) initiated 2 Mar 2008

    mislabeled - 300 micron flexipets labeled as 130 micron and vice versa

    • Terminated Z-2178-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007

    mislabeled - 300 micron flexipets were labeled as 80 microns

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  • Withdrawn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
MQH
Device Class
Class II
Regulation
21 CFR Part 884.6130
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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