510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001600Substantially Equivalent

<Genx> Coda Incubator Cellmate

<Genx> Intl., Inc., Madison CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001600 is the FDA 510(k) clearance record for <GENX> CODA INCUBATOR CELLMATE, a class II device, cleared for <Genx> Intl., Inc. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list 32 510(k) clearances for <Genx> Intl., Inc., from to . As of , FDA records show no recalls naming K001600.

Clearance record

Decision date
Received
(182 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
<Genx> Intl., Inc. 170 Fort Path Rd., Madison CT
510(k) summary
Statement
Third party review
No

Clearances, product code MQG

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