Cleared Traditional

K912934 - AMS SPHINCTER 800 URINARY PROSTHESIS (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K912934 · 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 3
Risk

K912934 is an FDA 510(k) clearance for the AMS SPHINCTER 800 URINARY PROSTHESIS. Classified as Prosthesis, Urethral Sphincter (product code FAG), Class III - Premarket Approval.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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.

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Submission Details

510(k) Number K912934 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
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 130d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FAG Prosthesis, Urethral Sphincter
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.