Cleared Traditional

SUR-FIT UROSTOMY POUCH & URINARY BAG (K800495) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K800495 · E. R. Squibb & Sons, Inc. · Gastroenterology & Urology device
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Apr 1980
Decision
35d
Days
Class 1
Risk

K800495 is an FDA 510(k) clearance for the SUR-FIT UROSTOMY POUCH & URINARY BAG. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 35 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 E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K800495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date April 08, 1980
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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.

Regulatory Peers - EXB Collector, Ostomy

All 101
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K800495.
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BARD IRYFIX(TM) STOMA CAP
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K852297 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD PERISTOMAL PASTE
K851398 · C.R. Bard, Inc. · May 1985
UNITED SKIN BARRIERS
K844046 · Howmedica Corp. · Nov 1984