510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033904Substantially Equivalent

Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)

Cook Incorporated, Spencer IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033904 is the FDA 510(k) clearance record for PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES), a class II device, cleared for Cook Urological, Inc. on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K033904.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary PDF
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