FDA PMA

Prosthesis, testicular

PMA Number: P020003 · 2026-07-21

ApplicantColoplast Corp.

Decision Date2026-07-21

PMA NumberP020003

Product CodeFAF

Device ClassClass 3

Medical SpecialtyG

Regulation Number21 CFR 8

Advisory CommitteeGU

Device Summary

Prosthesis, testicular is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code FAF. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Prosthesis, testicular?

Prosthesis, testicular is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Coloplast Corp..

When did Prosthesis, testicular receive FDA 510(k) clearance?

The clearance date for Prosthesis, testicular can be found in the official FDA records.

Who is the listed applicant for Prosthesis, testicular?

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

What is the FDA product code for Prosthesis, testicular?

The FDA product code for Prosthesis, testicular is FAF.

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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.