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FDA 510(k)

SILASTIC BRAND PENILE IMPLANT

K-Number: K780484 · 1978-07-17

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1978-07-17
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILASTIC BRAND PENILE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K780484. The device is classified under product code FIQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC BRAND PENILE IMPLANT?

SILASTIC BRAND PENILE IMPLANT is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K780484.

When did SILASTIC BRAND PENILE IMPLANT receive FDA 510(k) clearance?

SILASTIC BRAND PENILE IMPLANT received FDA 510(k) clearance on 1978-07-17, under 510(k) number K780484.

Who is the listed applicant for SILASTIC BRAND PENILE IMPLANT?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC BRAND PENILE IMPLANT?

The FDA product code for SILASTIC BRAND PENILE IMPLANT is FIQ.

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Other records listing Dow Corning Corp. Healthcare Industries Materials as applicant

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Related Devices (Code: FIQ)

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.

K892887ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULAAkcess Medical Products, Inc.K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.K841791PLUME FISTULA NEEDLEHospal Medical Corp.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.

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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