510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K014160Substantially Equivalent

Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014160 is the FDA 510(k) clearance record for PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES), a class II device, cleared for Cook Urological, Inc. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K014160.

Clearance record

Decision date
Received
(51 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code MQG

Trailing 12 months
2 clearances under product code MQG in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260