Cleared Traditional

SUR-FIT UROSTOMY POUCH W/ACCUSEAL (K840166) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K840166 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Feb 1984
Decision
19d
Days
Class 1
Risk

K840166 is an FDA 510(k) clearance for the SUR-FIT UROSTOMY POUCH W/ACCUSEAL. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 19 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K840166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1984
Decision Date February 04, 1984
Days to Decision 19 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
111d faster than avg
Panel avg: 130d · This submission: 19d
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 22
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K840166.
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · Johnson & Johnson Professionals, Inc. · Nov 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · Howmedica Corp. · Apr 1984
BARD KARAYA GUM WASHERS
K834575 · C.R. Bard, Inc. · Feb 1984
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp. · Nov 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · Howmedica Corp. · Jun 1981