Cleared Traditional

K863354 - BIO-GUARD AB COATED CATHETER

K863354 is the FDA 510(k) clearance for BIO-GUARD AB COATED CATHETER by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K863354 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
67d
Days
Class 2
Risk

K863354 is an FDA 510(k) clearance for the BIO-GUARD AB COATED CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K863354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1986
Decision Date November 04, 1986
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 102
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K863354.
VAN-TEC PUMPING SYSTEM
K870557 · Van-Tec, Inc. · Mar 1987
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
K870694 · Van-Tec, Inc. · Mar 1987
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.
K860337 · Van-Tec, Inc. · Mar 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985