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FDA 510(k)

VIRILIS PENILE PROSTHESIS

K-Number: K983015 · 1999-02-05

ApplicantSpecialty Surgical Products, Inc.
Decision Date1999-02-05
Product CodeFTQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VIRILIS PENILE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Surgical Products, Inc.. It received FDA 510(k) clearance on 1999-02-05 under 510(k) number K983015. The device is classified under product code FTQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRILIS PENILE PROSTHESIS?

VIRILIS PENILE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Specialty Surgical Products, Inc.. The 510(k) number is K983015.

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

VIRILIS PENILE PROSTHESIS received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983015.

Who is the listed applicant for VIRILIS PENILE PROSTHESIS?

The FDA 510(k) record lists Specialty Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRILIS PENILE PROSTHESIS?

The FDA product code for VIRILIS PENILE PROSTHESIS is FTQ.

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Other records listing Specialty Surgical Products, Inc. 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.

K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERK982258MAMMARY SIZERK982065STERILE SILICONE EXTERNAL WOUND COVERK982067MAGNETIC PORT SILICONE TISSUE EXPANDERK974653SILICONE ELASTOMER SHEETINGK974654SILICONE BLOCKS

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Related Devices (Code: FTQ)

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.

K830667SILICONE-SILVER PENILE PROSTHESIS-ESKDacomed Corp.

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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