Cleared Traditional

AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS (K896941) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896941 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Mar 1990
Decision
83d
Days
Class 2
Risk

K896941 is an FDA 510(k) clearance for the AMS DYNAFLEX SELF CONTAINED 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 6, 1990 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K896941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date March 06, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
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 31
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K896941.
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
K183619 · Boston Scientific Corporation · Apr 2019
Rigi10 Malleable Penile Prosthesis
K181673 · Rigicon, Inc. · Apr 2019
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · C.R. Bard, Inc. · Oct 1986