Cleared Traditional

K912344 - MODIFIED DURAPHASE(TM) IMPLANTED PENILE...

K912344 is the FDA 510(k) clearance for MODIFIED DURAPHASE(TM) IMPLANTED PENILE... by Dacomed Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K912344 · Dacomed Corp. · Gastroenterology & Urology device
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Oct 1991
Decision
136d
Days
Class 2
Risk

K912344 is an FDA 510(k) clearance for the MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dacomed Corp. devices

Submission Details

510(k) Number K912344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date October 11, 1991
Days to Decision 136 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 130d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAE Prosthesis, Penile

All 19
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K912344.
AMS AMBICOR PENILE PROSTHESIS
K963328 · American Medical Systems, Inc. · Dec 1996
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · American Medical Systems, Inc. · Jul 1995
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935 · American Medical Systems, Inc. · Mar 1992
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · Mentor Corp. · Nov 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · American Medical Systems, Inc. · Jun 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · American Medical Systems, Inc. · Mar 1990