Cleared Traditional

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K963950 · Bioderm, Inc. · Gastroenterology & Urology device
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Jan 1997
Decision
100d
Days
Class 1
Risk

K963950 is an FDA 510(k) clearance for the BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE. Classified as Device, Paste-on For Incontinence, Sterile (product code EXI), Class I - General Controls.

Submitted by Bioderm, Inc. (East Burnswick, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Bioderm, Inc. devices

Submission Details

510(k) Number K963950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date January 10, 1997
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXI Device, Paste-on For Incontinence, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.