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FDA 510(k)

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS

K-Number: K910214 · 1991-04-25

ApplicantAmerican Medical Corp.
Decision Date1991-04-25
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Corp.. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K910214. 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 AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS?

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is American Medical Corp.. The 510(k) number is K910214.

When did AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS receive FDA 510(k) clearance?

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS received FDA 510(k) clearance on 1991-04-25, under 510(k) number K910214.

Who is the listed applicant for AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS?

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

What is the FDA product code for AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS?

The FDA product code for AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS is FAE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Medical 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.

K922493AMERICAN MEDICAL MFG. LUMBAR CPMK915067DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS

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

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

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