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FDA 510(k)

MENTOR GENESIS PENILE PROSTHESIS

K-Number: K040959 · 2004-10-29

ApplicantMentor Corp.
Decision Date2004-10-29
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR GENESIS PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K040959. 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 MENTOR GENESIS PENILE PROSTHESIS?

MENTOR GENESIS PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Mentor Corp.. The 510(k) number is K040959.

When did MENTOR GENESIS PENILE PROSTHESIS receive FDA 510(k) clearance?

MENTOR GENESIS PENILE PROSTHESIS received FDA 510(k) clearance on 2004-10-29, under 510(k) number K040959.

Who is the listed applicant for MENTOR GENESIS PENILE PROSTHESIS?

The FDA 510(k) record lists Mentor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR GENESIS PENILE PROSTHESIS?

The FDA product code for MENTOR GENESIS PENILE PROSTHESIS is FAE.

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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.K963328AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.K953640DUNA II PENILE PROSTHESISDacomed Corp.

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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