Cleared Traditional

K863492 - METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.

K863492 is an FDA 510(k) clearance for METAL TIPPED URETER. STENT & MAGNETIC S..., 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 100-day FDA review.

K863492 · Surgitek · Gastroenterology & Urology device
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Dec 1986
Decision
100d
Days
Class 2
Risk

K863492 is an FDA 510(k) clearance for the METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on December 18, 1986 after a review of 100 days - within the typical 510(k) review window.

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. 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.

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FDA 510(k) Submission Details - K863492

510(k) Number K863492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date December 18, 1986
Days to Decision 100 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
31d faster than avg
Panel avg: 131d · This submission: 100d
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 K863492.
SURGITEK INFUSION STENT SYSTEM*
K872353 · Surgitek · Sep 1987
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · Van-Tec, Inc. · Mar 1987
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K864225 · Angiomed U.S., Inc. · Jan 1987
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · Mentor Corp. · Sep 1986
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · C.R. Bard, Inc. · May 1986
MARDIS DANGLER URETERAL STENT SET
K860267 · Van-Tec, Inc. · Apr 1986