Cleared Traditional

K912935 - AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS

K912935 is an FDA 510(k) clearance for AMS MALLEABLE 600 AND 600M PENILE PROST..., manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAE cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K912935 · American Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
257d
Days
Class 2
Risk

K912935 is an FDA 510(k) clearance for the AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 257 days - an extended review cycle.

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 American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K912935

510(k) Number K912935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date March 18, 1992
Days to Decision 257 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 131d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAE Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K912935.
DUNA II PENILE PROSTHESIS
K953640 · Dacomed Corp. · Oct 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · American Medical Systems, Inc. · Jul 1995
DURA II PENILE PROSTHESIS
K920420 · Dacomed Corp. · Apr 1992
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
K912344 · Dacomed Corp. · Oct 1991
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · Mentor Corp. · Nov 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · American Medical Systems, Inc. · Jun 1990