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The Inflatable Penile Prosthesis

by American Medical Systems, Inc.

510(k) K821628

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 NumberK821628 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  • Withdrawn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)

510(k) Number
FDA product code
FAE
Device class
Class II
Regulation
21 CFR Part 876.3630
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 AMS 700 Inflatable Penile Prosthesis is a three-piece inflatable penile implant designed for the treatment of chronic, organic male erectile dysfunction. It consists of paired cylinders, a reservoir, and a pump mechanism that allows the patient to control inflation and deflation. The device is intended for use in patients who have not responded to other therapies and is contraindicated in those with active urogenital or skin infections in the surgical region.

The device is supplied sterile for single-use implantation and is intended to be surgically placed by a trained urologist. It is regulated as a Class II medical device under product code FAE and is authorized through the FDA 510(k) process. The prosthesis is available in multiple sizes to accommodate anatomical variation and should be stored in a dry, controlled environment prior to use.

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Questions

AI-generated answers, 28 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 condition is the AMS 700 designed to treat?

    The AMS 700 Inflatable Penile Prosthesis is indicated for chronic, organic male erectile dysfunction in patients who have not responded to other therapies. It is contraindicated in individuals with active urogenital or skin infections in the surgical region.

  • How is the device supplied and prepared for use?

    The device is supplied sterile for single-use implantation. It must be surgically placed by a trained urologist and is not intended for reuse or reprocessing. Storage should be in a dry, controlled environment prior to surgery.

  • What components make up the AMS 700 system?

    The AMS 700 is a three-piece system consisting of paired cylinders, a reservoir, and a pump mechanism. This design allows the patient to control inflation and deflation of the implant for functional use.

  • Is the device available in different sizes?

    Yes, the AMS 700 is available in multiple sizes to accommodate anatomical variation among patients. The appropriate size is selected by the surgeon based on individual patient anatomy during preoperative assessment.

  • What regulatory classification applies to this device?

    The AMS 700 is regulated as a Class II medical device under product code FAE. It was authorized through the FDA 510(k) process, with a determination of substantial equivalence based on its safety and performance profile.