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Artificial Urinary Sphincter

by American Medical Systems, Inc.

510(k) K821627

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

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 NumberK821627 Date10 Aug 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
The Artificial Urinary Sphincter
510(k) Number
FDA product code
FAG
Device class
Class III
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Artificial Urinary Sphincter is a Class III implantable prosthesis designed to restore urinary continence in males with intrinsic sphincter deficiency. It functions as a mechanical substitute for the natural urethral sphincter, using a fluid-filled silicone elastomer cuff to control urethral closure and opening via a patient-activated pump mechanism.

This device is implanted surgically and is intended for single-use, permanent implantation. It is supplied sterile and requires sterile surgical techniques for installation. Approved under FDA 510(k) clearance (K821627), it is regulated as a urethral sphincter prosthesis under product code FAG, with no MRI safety restrictions specified.

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Questions

AI-generated answers, 18 Sep 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 Artificial Urinary Sphincter used for in clinical practice?

    The Artificial Urinary Sphincter is designed to restore urinary continence in males who experience intrinsic sphincter deficiency, meaning their natural urethral sphincter no longer functions properly. It acts as a mechanical replacement to help control urine flow by using a fluid-filled silicone cuff around the urethra, which can be manually activated by the patient via an implanted pump.

  • Is this device intended for temporary use or permanent implantation?

    This device is explicitly intended for single-use, permanent implantation after surgical placement. It is not designed for removal or reuse, and once implanted, it remains in place as a long-term solution for urinary continence.

  • How is the Artificial Urinary Sphincter supplied, and what precautions must be taken during handling?

    The device is supplied sterile and must be handled using sterile surgical techniques during implantation. Since it is an implantable prosthesis, contamination during surgery could compromise patient safety, so adherence to aseptic protocols is critical.

  • Are there any size variations or models available for this device?

    The provided data does not specify distinct size variations or model numbers for the Artificial Urinary Sphincter. However, sizing would typically be determined intraoperatively based on patient anatomy, as the device is custom-fitted during surgery to ensure proper function and comfort.

  • Can this device be used in patients who require MRI scans, or are there any restrictions?

    The documentation does not explicitly state MRI safety restrictions for this device, but it is generally advisable to confirm compatibility with the specific MRI system and protocol before imaging. Since it is an implanted prosthesis, potential risks like heating or displacement should be evaluated on a case-by-case basis.