Cleared Traditional

CLAMP, INCONTINENCE, BAUMRUCKER (K780137) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K780137 · Greenwald Surgical Co., Inc. · Gastroenterology & Urology device
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Apr 1978
Decision
93d
Days
Class 1
Risk

K780137 is an FDA 510(k) clearance for the CLAMP, INCONTINENCE, BAUMRUCKER. Classified as Clamp, Penile (product code FHA), Class I - General Controls.

Submitted by Greenwald Surgical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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 Greenwald Surgical Co., Inc. devices

Submission Details

510(k) Number K780137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1978
Decision Date April 28, 1978
Days to Decision 93 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
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FHA Clamp, Penile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.