510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962816Substantially Equivalent

Sperm Preparation Media

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

K962816 is the FDA 510(k) clearance record for SPERM PREPARATION MEDIA, a class II device, cleared for Genx Intl., Inc. on under FDA product code MOL (Condom, Synthetic). FDA records list 32 510(k) clearances for Genx Intl., Inc., from to . As of , FDA records show no recalls naming K962816.

Clearance record

Decision date
Received
(130 days to decision)
Product code
MOL Condom, Synthetic
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Genx Intl., Inc. 339 Bartlett Dr., Madison CT
510(k) summary
Summary
Third party review
No

Clearances, product code MOL

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