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FDA 510(k)

OMNI PHASE PENILE PROSTHESIS

K-Number: K850019 · 1985-04-09

ApplicantDacomed Corp.
Decision Date1985-04-09
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNI PHASE PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Dacomed Corp.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K850019. 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 OMNI PHASE PENILE PROSTHESIS?

OMNI PHASE PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Dacomed Corp.. The 510(k) number is K850019.

When did OMNI PHASE PENILE PROSTHESIS receive FDA 510(k) clearance?

OMNI PHASE PENILE PROSTHESIS received FDA 510(k) clearance on 1985-04-09, under 510(k) number K850019.

Who is the listed applicant for OMNI PHASE PENILE PROSTHESIS?

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

What is the FDA product code for OMNI PHASE PENILE PROSTHESIS?

The FDA product code for OMNI PHASE PENILE PROSTHESIS is FAE.

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Other records listing Dacomed 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.

K953640DUNA II PENILE PROSTHESISK941781RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMK920409DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEK920420DURA II PENILE PROSTHESISK912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISK900774DACOMED NEGATIVE PRESSURE ERECTION DEVICE

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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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