510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013497Substantially Equivalent

Fas Set #4551

Gynetics Medical Products NV, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013497 is the FDA 510(k) clearance record for FAS SET #4551, a class II device, cleared for Gynetics Medical Products NV on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 4 510(k) clearances for Gynetics Medical Products NV, from to . As of , FDA records show no recalls naming K013497.

Clearance record

Decision date
Received
(18 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynetics Medical Products NV 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code MQE

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