510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K990847Substantially Equivalent

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

CooperSurgical, Inc., Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990847 is the FDA 510(k) clearance record for INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M, a class II device, cleared for Humagen Fertility Diagnostics, Inc. on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show one recall naming K990847.

Clearance record

Decision date
Received
(121 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Humagen Fertility Diagnostics, Inc. 2400 Hunter'S Way, Charlottesville VA
510(k) summary
Summary
Third party review
No

Clearances, product code MQH

Trailing 12 months

FDA records hold no clearances under product code MQH in the trailing twelve months.

FDA records show no clearances under product code MQH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260