Cleared Traditional

K912851 - NAUDE URETHRAL STENT

K912851 is the FDA 510(k) clearance for NAUDE URETHRAL STENT by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K912851 · Cook Urological, Inc. · Gastroenterology & Urology device
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Jan 1992
Decision
216d
Days
Class 2
Risk

K912851 is an FDA 510(k) clearance for the NAUDE URETHRAL STENT. 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 January 30, 1992 after a review of 216 days - an extended review 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: 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K912851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date January 30, 1992
Days to Decision 216 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 130d · This submission: 216d
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 K912851.
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992
KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.
K921054 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1992
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1991
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990