Cleared Traditional

K880100 - COOK UROLOGICAL WIRE GUIDE W/HYDROMER C...

K880100 is the FDA 510(k) clearance for COOK UROLOGICAL WIRE GUIDE W/HYDROMER C... by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K880100 · Cook Urological, Inc. · Gastroenterology & Urology device
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Mar 1988
Decision
63d
Days
Class 2
Risk

K880100 is an FDA 510(k) clearance for the COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING. 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 March 15, 1988 after a review of 63 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 K880100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date March 15, 1988
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
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 K880100.
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K881781 · Baxter Healthcare Corp · Aug 1988
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PHARMASEAL RUBBER URETHRAL CATHETER
K874517 · American Pharmaseal Div. Ahsc · Dec 1987
ANTIMICROBIAL FOLEY CATHETER
K871429 · American Pharmaseal Div. Ahsc · Aug 1987