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Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M

by Humagen Fertility Diagnostics, Inc.

510(k) K990847

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990847 Date14 Jul 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1367-2019 FDA Class II initiated 27 Mar 2019

    ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

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  • Withdrawn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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