Cleared Traditional

K831446 - SURGITEK NEPHROSTENT KIT

K831446 is an FDA 510(k) clearance for SURGITEK NEPHROSTENT KIT, manufactured by Mec/Surgitek Products. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831446 · Mec/Surgitek Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
48d
Days
Class 2
Risk

K831446 is an FDA 510(k) clearance for the SURGITEK NEPHROSTENT KIT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Mec/Surgitek Products (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 48 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.

FDA 510(k) Submission Details - K831446

510(k) Number K831446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1983
Decision Date June 22, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
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 113
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K831446.
SILITEK URINARY DIVERSION STENT
K840059 · Surgitek · Feb 1984
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · Surgitek · Oct 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · Medical Engineering Corp. · Aug 1983
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983
SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
K830884 · Medical Engineering Corp. · May 1983
URETERAL STANT SET
K820870 · Van-Tec, Inc. · Apr 1982