510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053208Substantially Equivalent

Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set

Swemed Lab International AB, Billdal, SE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053208 is the FDA 510(k) clearance record for CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET, a class II device, cleared for Swemed Lab International AB on under FDA product code MQF (Catheter, Assisted Reproduction). FDA records list 4 510(k) clearances for Swemed Lab International AB, from to . As of , FDA records show no recalls naming K053208.

Clearance record

Decision date
Received
(75 days to decision)
Product code
MQF Catheter, Assisted Reproduction
Regulation
21 CFR 884.6110
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Swemed Lab International AB Billdalsvagen 2, Billdal, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQF

Trailing 12 months
1 clearance under product code MQF 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 MQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260