Cleared Traditional

K896941 - AMS DYNAFLEX SELF CONTAINED PENILE PROS...

K896941 is the FDA 510(k) clearance for AMS DYNAFLEX SELF CONTAINED PENILE PROS... by American Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

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
Combination Product No
PCCP Authorized No
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 18
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K896941.
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
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K890402 · Mentor Corp. · Aug 1989
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · C.R. Bard, Inc. · Oct 1986
MENTOR CORPORAL DILATORS
K860517 · Mentor Corp. · Mar 1986