Cleared Traditional

K952513 - LESE STENTS SETS

K952513 is the FDA 510(k) clearance for LESE STENTS SETS by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K952513 · Cook Urological, Inc. · Gastroenterology & Urology device
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Jun 1996
Decision
377d
Days
Class 2
Risk

K952513 is an FDA 510(k) clearance for the LESE STENTS SETS. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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. Elevated predicate reliance profile. 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 K952513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date June 10, 1996
Days to Decision 377 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 130d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 69
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K952513.
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K983498 · C.R. Bard, Inc. · Dec 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · Boston Scientific Corp · Feb 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996
AQ HYDROPHILIC STENT
K961446 · Cook Urological, Inc. · May 1996
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993