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Ams Collagen Dermal Matrix

by American Medical Systems, Inc.

510(k) K050445

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050445 Date17 Jun 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0932-2009 FDA Unclassified (pre-2012) initiated 5 Dec 2008 on shared 510(k) K050445

    The product size shown on the carton labeling does not match the size on the product inside.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PAG
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ams Collagen Dermal Matrix is a non-synthetic, urogynecologic mesh for stress urinary incontinence, retropubic or transobturator. It consists of decellularized porcine dermis, lyophilized and terminally sterilized. The device is provided as a standalone matrix or pre-connected to polypropylene mesh systems. It is used in vaginal vault suspension to treat pelvic organ prolapse. The matrix is also intended for use in the treatment of hernias where connective tissue has been compromised.

The Ams Collagen Dermal Matrix is supplied in various sizes, including 8 x 12 cm. It is a sterile, non-perforated processed porcine collagen dermal matrix, sterilized using ethylene oxide. The device has been authorized with an FDA 510(k) clearance, with the reference number K050445. The matrix is distributed by American Medical Systems, Inc.

Other devices from American Medical Systems, Inc.

See all devices from American Medical Systems, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ams Collagen Dermal Matrix made of?

    The Ams Collagen Dermal Matrix is made from decellularized porcine dermis, which is lyophilized and terminally sterilized using ethylene oxide.

  • What are the intended uses of the Ams Collagen Dermal Matrix?

    The Ams Collagen Dermal Matrix is intended for use in the treatment of stress urinary incontinence, retropubic or transobturator, vaginal vault suspension to treat pelvic organ prolapse, and hernias where connective tissue has been compromised.

  • How is the Ams Collagen Dermal Matrix supplied?

    The Ams Collagen Dermal Matrix is supplied in various sizes, including 8 x 12 cm, as a standalone matrix or pre-connected to polypropylene mesh systems, and is sterile and non-perforated.