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
K954099Substantially Equivalent

Select Iui

Select Medical Systems, Inc., Williston VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954099 is the FDA 510(k) clearance record for SELECT IUI, a class II device, cleared for Select Medical Systems, Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 6 510(k) clearances for Select Medical Systems, Inc., from to . As of , FDA records show no recalls naming K954099.

Clearance record

Decision date
Received
(83 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Select Medical Systems, Inc. 2 Wintersport Ln., Williston VT
510(k) summary
Summary
Third party review
No

Clearances, product code MFD

Trailing 12 months

FDA records hold no clearances under product code MFD in the trailing twelve months.

FDA records show no clearances under product code MFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260