Cleared Traditional

K863082 - COOK-VPI INTERMITTENT CATHETER

K863082 is an FDA 510(k) clearance for COOK-VPI INTERMITTENT CATHETER, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K863082 · Cook Urological, Inc. · Gastroenterology & Urology device
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Nov 1986
Decision
87d
Days
Class 2
Risk

K863082 is an FDA 510(k) clearance for the COOK-VPI INTERMITTENT 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 7, 1986 after a review of 87 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.

FDA 510(k) Submission Details - K863082

510(k) Number K863082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date November 07, 1986
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

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 210
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K863082.
AKRO-SIL PLUS
K864736 · Akron Catheter, Inc. · Dec 1986
CATHETER VALVES KV 100 & KV 100EH
K861699 · Max Staubli , Ltd. · Nov 1986
PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH
K862098 · Hall/Mccollum Laboratories, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY
K863958 · Cathaid, Inc. · Nov 1986
CARE + PLUS IRREGATION TRAY
K863281 · Welmed Systems, Inc. · Oct 1986
K863082 · COOK-VPI INTERMITTENT CATHETER
Download PDF Cook Urological, Inc.