Amielle

FDA 510(k) K983045 · Owen Mumford USA, Inc.

Substantially Equivalent

510(k) numberK983045

Submission

Device name
Amielle
Applicant
Owen Mumford USA, Inc.
Marietta, GA, US
Received
September 1, 1998
Decision date
November 25, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXP – Stent, Vaginal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.3900
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code KXP

510(k)DeviceApplicantDecision
K202542Allura Vaginal StentKXP · Traditional Pmt Corporation09/30/2020SE
K974479Silimed Vaginal StentKXP · Traditional Silimed, LLC08/05/1998SE
K920633Pessary Flexible Silicone NicholsKXP · Traditional Bioteque America, Inc.11/08/1995SE

More from Bioteque America, Inc.

510(k)DeviceDecision
K013362Autoject 2KZH · Traditional 11/13/2001SE
K993385Autojet 2 (Non-Fixed Needle Type)KZH · Traditional 11/10/1999SE
K983994UnifineFMF · Traditional 01/08/1999SE
K983974Owen Mumford 3ML AutopenFMF · Traditional 12/21/1998SE
K982275Rapport V.T.D.LKY · Traditional 12/04/1998SE
K973899Unifine PentipsFMI · Traditional 12/04/1997SE
K971443Rapport V.T.D.LKY · Traditional 09/26/1997SE
K953735Autoject MiniKZH · Traditional 11/08/1995SE
K945660Autoject 2KZH · Traditional 08/11/1995SE

Questions and answers

When was Amielle cleared by the FDA?

Amielle (K983045) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 85 days after the submission was received.

What is the product code of K983045?

The FDA product code is KXP – Stent, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.