Cleared Traditional

K931277 - HOLLISTER PREMIUM URINE COLLECTOR (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K931277 · Hollister, Inc. · Gastroenterology & Urology device
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Jun 1993
Decision
107d
Days
Class 1
Risk

K931277 is an FDA 510(k) clearance for the HOLLISTER PREMIUM URINE COLLECTOR. Classified as Device, Paste-on For Incontinence, Sterile (product code EXI), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on June 23, 1993 after a review of 107 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 Hollister, Inc. devices

Submission Details

510(k) Number K931277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 23, 1993
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 130d · This submission: 107d
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.