Cleared Traditional

K821627 - THE ARTIFICIAL URINARY SPHINCTER (FDA 510(k) Clearance)

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

K821627 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Aug 1982
Decision
69d
Days
Class 3
Risk

K821627 is an FDA 510(k) clearance for the THE ARTIFICIAL URINARY SPHINCTER. Classified as Prosthesis, Urethral Sphincter (product code FAG), Class III - Premarket Approval.

Submitted by American Medical Systems, Inc. (Walker, US). The FDA issued a Cleared decision on August 10, 1982 after a review of 69 days - a notably fast clearance 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 K821627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date August 10, 1982
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
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.