Cleared Traditional

BARD IRYFIX(TM) STOMA CAP (K862631) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K862631 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
98d
Days
Class 1
Risk

K862631 is an FDA 510(k) clearance for the BARD IRYFIX(TM) STOMA CAP. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 98 days - within the typical 510(k) review window.

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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K862631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date October 16, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 130d · This submission: 98d
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 K862631.
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BARD PERISTOMAL PASTE
K851398 · C.R. Bard, Inc. · May 1985
UNITED SKIN BARRIERS
K844046 · Howmedica Corp. · Nov 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · Howmedica Corp. · Apr 1984
BARD KARAYA GUM WASHERS
K834575 · C.R. Bard, Inc. · Feb 1984