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FDA 510(k)

SURGITEK SIZER FOR PENILE PROSTHESIS

K-Number: K830917 · 1983-04-12

ApplicantMedical Engineering Corp.
Decision Date1983-04-12
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK SIZER FOR PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830917. 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 SURGITEK SIZER FOR PENILE PROSTHESIS?

SURGITEK SIZER FOR PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Medical Engineering Corp.. The 510(k) number is K830917.

When did SURGITEK SIZER FOR PENILE PROSTHESIS receive FDA 510(k) clearance?

SURGITEK SIZER FOR PENILE PROSTHESIS received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830917.

Who is the listed applicant for SURGITEK SIZER FOR PENILE PROSTHESIS?

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

What is the FDA product code for SURGITEK SIZER FOR PENILE PROSTHESIS?

The FDA product code for SURGITEK SIZER FOR PENILE PROSTHESIS is FAE.

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Other records listing Medical Engineering 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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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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