Cleared Traditional

K813269 - TWO PIECE OSTOMY SYSTEM (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K813269 · Hollister, Inc. · Gastroenterology & Urology device
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Dec 1981
Decision
13d
Days
Class 1
Risk

K813269 is an FDA 510(k) clearance for the TWO PIECE OSTOMY SYSTEM. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hollister, Inc. devices

Submission Details

510(k) Number K813269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1981
Decision Date December 03, 1981
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
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.