Cleared Traditional

THE POUCH GROIN & ABDOMINAL STRESS AID (K892379) - FDA 510(k) Clearance

Class I General Hospital device.

K892379 · Kuhn Industries · General Hospital
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Jul 1989
Decision
105d
Days
Class 1
Risk

K892379 is an FDA 510(k) clearance for the THE POUCH GROIN & ABDOMINAL STRESS AID. Classified as Binder, Abdominal (product code FSD), Class I - General Controls.

Submitted by Kuhn Industries (Kent, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5160 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K892379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date July 20, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSD Binder, Abdominal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5160
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.