Cleared Traditional

K946296 - QUADRA-COIL URETERAL STENT

K946296 is an FDA 510(k) clearance for QUADRA-COIL URETERAL STENT, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K946296 · Surgitek · Gastroenterology & Urology device
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Mar 1995
Decision
69d
Days
Class 2
Risk

K946296 is an FDA 510(k) clearance for the QUADRA-COIL URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 69 days - a notably fast clearance cycle.

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: 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 Surgitek devices

FDA 510(k) Submission Details - K946296

510(k) Number K946296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date March 06, 1995
Days to Decision 69 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
62d faster than avg
Panel avg: 131d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K946296.
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996
AQ HYDROPHILIC STENT
K961446 · Cook Urological, Inc. · May 1996
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
K960148 · Cabot Medical Corp. · Mar 1996
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
SURGITEK INFUSER
K941952 · Surgitek · May 1994
MENLO CARE URINARY DIVERSION STENT
K933941 · Menlo Care, Inc. · Mar 1994