Cleared Traditional

K871313 - ULTRA-FRESH DEODORANT (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K871313 · Mentor Corp. · Gastroenterology & Urology device
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Mar 1988
Decision
336d
Days
Class 1
Risk

K871313 is an FDA 510(k) clearance for the ULTRA-FRESH DEODORANT. Classified as Bag, Stomal (product code GDS), Class I - General Controls.

Submitted by Mentor Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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. Elevated predicate reliance 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 K871313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date March 02, 1988
Days to Decision 336 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
206d slower than avg
Panel avg: 130d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDS Bag, Stomal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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.