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FDA 510(k)

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES

K-Number: K900371 · 1990-11-02

ApplicantMentor Corp.
Decision Date1990-11-02
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K900371. 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 MODIFIED MALLEABLE PENILE PROSTHESES?

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Mentor Corp.. The 510(k) number is K900371.

When did MENTOR MODIFIED MALLEABLE PENILE PROSTHESES receive FDA 510(k) clearance?

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES received FDA 510(k) clearance on 1990-11-02, under 510(k) number K900371.

Who is the listed applicant for MENTOR MODIFIED MALLEABLE PENILE PROSTHESES?

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 MODIFIED MALLEABLE PENILE PROSTHESES?

The FDA product code for MENTOR MODIFIED MALLEABLE PENILE PROSTHESES is FAE.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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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