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FDA PMA

Device, impotence, mechanical/hydraulic

PMA Number: P000006 · 2026-08-13

ApplicantColoplast Corp.
Decision Date2026-08-13
PMA NumberP000006
Product CodeFHW
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeGU

Device Summary

Device, impotence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-08-13. The device is classified under product code FHW. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Device, impotence, mechanical/hydraulic?

Device, impotence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Coloplast Corp..

When did Device, impotence, mechanical/hydraulic receive FDA 510(k) clearance?

The clearance date for Device, impotence, mechanical/hydraulic can be found in the official FDA records.

Who is the listed applicant for Device, impotence, mechanical/hydraulic?

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 Device, impotence, mechanical/hydraulic?

The FDA product code for Device, impotence, mechanical/hydraulic is FHW.

Related Clinical Trials

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.

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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.

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