510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161261Substantially Equivalent

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

GENEA BIOMEDX Pty Ltd., Sydney, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161261 is the FDA 510(k) clearance record for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase, a class II device, cleared for Genea Biomedx Pty, Ltd. on under FDA product code MQL (Media, Reproductive). FDA records list 6 510(k) clearances for Genea Biomedx Pty, Ltd., from to . As of , FDA records show no recalls naming K161261.

Clearance record

Decision date
Received
(373 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Genea Biomedx Pty, Ltd. Level 2, 321 Kent St., Sydney, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQL

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