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Dura II Penile Prosthesis

by Dacomed Corp. 510(k)

Active United States

510(k) K920420

Overview

The Dura II Penile Prosthesis is a penile prosthesis designed for surgical implantation. It functions as a medical device to address urological conditions requiring prosthetic intervention.

This device is identified by FDA 510(k) number K920420 and is classified as a class 2 medical device under regulation number 876.3630. It is manufactured by Dacomed Corp. and received traditional 510(k) clearance on April 16, 1992.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920420 Date16 Apr 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FAE
Device Class
Class II
Regulation
21 CFR Part 876.3630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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See all devices from Dacomed Corp. →