510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012811Substantially Equivalent

Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-Mbb,10-Mbb-B,10-Mpb,10-Mpb-B

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

K012811 is the FDA 510(k) clearance record for BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B, 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 no recalls naming K012811.

Clearance record

Decision date
Received
(173 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
1 clearance under product code MQH in the twelve months to November 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260