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FDA 510(k)

FLEXI-FLATE PENILE IMPLANT

K-Number: K834347 · 1984-04-02

ApplicantSurgitek
Decision Date1984-04-02
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXI-FLATE PENILE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1984-04-02 under 510(k) number K834347. 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 FLEXI-FLATE PENILE IMPLANT?

FLEXI-FLATE PENILE IMPLANT is a medical device that received FDA 510(k) clearance on 1984-04-02. The listed applicant is Surgitek. The 510(k) number is K834347.

When did FLEXI-FLATE PENILE IMPLANT receive FDA 510(k) clearance?

FLEXI-FLATE PENILE IMPLANT received FDA 510(k) clearance on 1984-04-02, under 510(k) number K834347.

Who is the listed applicant for FLEXI-FLATE PENILE IMPLANT?

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

What is the FDA product code for FLEXI-FLATE PENILE IMPLANT?

The FDA product code for FLEXI-FLATE PENILE IMPLANT is FAE.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

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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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