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
K161970Substantially Equivalent

Follicle Aspiration Set

Vitrolife Sweden AB, Västra Frölunda, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161970 is the FDA 510(k) clearance record for Follicle Aspiration Set, a class II device, cleared for Vitrolife Sweden AB on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 38 510(k) clearances for Vitrolife Sweden AB, from to . As of , FDA records show no recalls naming K161970.

Clearance record

Decision date
Received
(331 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Vitrolife Sweden AB Gustaf Werners Gata 2, Västra Frölunda, SE
510(k) summary
Summary PDF
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