510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991273Substantially Equivalent

Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle

Swemed Lab International AB, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991273 is the FDA 510(k) clearance record for SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE, a class II device, cleared for Swemed Lab International AB on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 4 510(k) clearances for Swemed Lab International AB, from to . As of , FDA records show no recalls naming K991273.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Swemed Lab International AB 555 13th St., NW, Washington DC
510(k) summary
Summary
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