Silimed Vaginal Stent

FDA 510(k) K974479 · Silimed, LLC

Substantially Equivalent

510(k) numberK974479

Submission

Device name
Silimed Vaginal Stent
Applicant
Silimed, LLC
Crofton, MD, US
Received
November 26, 1997
Decision date
August 5, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K983045AmielleKXP · Traditional Owen Mumford USA, Inc.11/25/1998SE
K920633Pessary Flexible Silicone NicholsKXP · Traditional Bioteque America, Inc.11/08/1995SE

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K981835Silimed Malar ImplantLZK · Traditional 07/09/1998SE
K981833Silimed Nasal L Shaped ImplantFZE · Traditional 06/26/1998SE
K980221Silimed Nasal RetainerLYA · Traditional 04/02/1998SE
K974482Silimed Gluteal ImplantMIB · Traditional 02/24/1998SE
K974480Silimed Calf ImplantMIB · Traditional 02/24/1998SE

Questions and answers

When was Silimed Vaginal Stent cleared by the FDA?

Silimed Vaginal Stent (K974479) received a 510(k) decision of Substantially Equivalent on August 5, 1998, 252 days after the submission was received.

What is the product code of K974479?

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