Cleared Traditional

K873036 - ATTENDS INCONTINENT BRIEF (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K873036 · Procter & Gamble Mfg. Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
168d
Days
Class 1
Risk

K873036 is an FDA 510(k) clearance for the ATTENDS INCONTINENT BRIEF. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5920 - 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K873036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date January 19, 1988
Days to Decision 168 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
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYQ Garment, Protective, For Incontinence
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5920
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.