Cleared Traditional

K863302 - MODIFIED FOLEY CATHETER

K863302 is the FDA 510(k) clearance for MODIFIED FOLEY CATHETER by Sheridan Catheter Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K863302 · Sheridan Catheter Corp. · Gastroenterology & Urology device
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Oct 1986
Decision
39d
Days
Class 2
Risk

K863302 is an FDA 510(k) clearance for the MODIFIED FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 39 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K863302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date October 03, 1986
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
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 69
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K863302.
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · Cook Urological, Inc. · Mar 1988
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · Abco Dealers, Inc. · Jul 1984