510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K171736Substantially Equivalent

Geri Embryo Incubator and Geri Dish

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

K171736 is the FDA 510(k) clearance record for Geri Embryo Incubator and Geri Dish, a class II device, cleared for Genea Biomedx Pty, Ltd. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list 6 510(k) clearances for Genea Biomedx Pty, Ltd., from to . As of , FDA records show no recalls naming K171736.

Clearance record

Decision date
Received
(156 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
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 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