510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983596Substantially Equivalent

Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching

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

K983596 is the FDA 510(k) clearance record for INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING, a class II device, cleared for Cook Ob/Gyn on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 43 510(k) clearances for Cook Ob/Gyn, from to . As of , FDA records show 3 recalls naming K983596.

Clearance record

Decision date
Received
(115 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 Ob/Gyn 1100 W. Morgan St., Spencer IN
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