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
K983045Substantially Equivalent

Amielle

Owen Mumford USA, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983045 is the FDA 510(k) clearance record for AMIELLE, a class II device, cleared for Owen Mumford USA, Inc. on under FDA product code KXP (Stent, Vaginal). FDA records list 10 510(k) clearances for Owen Mumford USA, Inc., from to . As of , FDA records show no recalls naming K983045.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KXP Stent, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Owen Mumford USA, Inc. 849 Pickens Industrial Dr., Marietta GA
510(k) summary
Summary
Third party review
No

Clearances, product code KXP

Trailing 12 months

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

FDA records show no clearances under product code KXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXP, 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