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FDA 510(k)

THE INFLATABLE PENILE PROSTHESIS

K-Number: K821628 · 1982-08-10

ApplicantAmerican Medical Systems, Inc.
Decision Date1982-08-10
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE INFLATABLE PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-08-10 under 510(k) number K821628. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE INFLATABLE PENILE PROSTHESIS?

THE INFLATABLE PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K821628.

When did THE INFLATABLE PENILE PROSTHESIS receive FDA 510(k) clearance?

THE INFLATABLE PENILE PROSTHESIS received FDA 510(k) clearance on 1982-08-10, under 510(k) number K821628.

Who is the listed applicant for THE INFLATABLE PENILE PROSTHESIS?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE INFLATABLE PENILE PROSTHESIS?

The FDA product code for THE INFLATABLE PENILE PROSTHESIS is FAE.

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Other records listing American Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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Related Devices (Code: FAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific CorporationK181673Rigi10 Malleable Penile ProsthesisRigicon, Inc.K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K040959MENTOR GENESIS PENILE PROSTHESISMentor Corp.K963328AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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