Cleared Traditional

K792724 - AMS MALLEABLE OR JONAS SILICONE-SILVER

K792724 is the FDA 510(k) clearance for AMS MALLEABLE OR JONAS SILICONE-SILVER 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 253-day FDA review.

K792724 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Sep 1980
Decision
253d
Days
Class 2
Risk

K792724 is an FDA 510(k) clearance for the AMS MALLEABLE OR JONAS SILICONE-SILVER. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 253 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

Submission Details

510(k) Number K792724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1979
Decision Date September 09, 1980
Days to Decision 253 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
123d slower than avg
Panel avg: 130d · This submission: 253d
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.