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FDA 510(k)

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER

K-Number: K901482 · 1990-06-27

ApplicantAmerican Medical Systems, Inc.
Decision Date1990-06-27
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER 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 1990-06-27 under 510(k) number K901482. 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 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER?

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER is a medical device that received FDA 510(k) clearance on 1990-06-27. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K901482.

When did 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER receive FDA 510(k) clearance?

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER received FDA 510(k) clearance on 1990-06-27, under 510(k) number K901482.

Who is the listed applicant for 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER?

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 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER?

The FDA product code for 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER is FAE.

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Other records listing American Medical Systems, Inc. as applicant

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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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