Cleared Traditional

K820870 - URETERAL STANT SET

K820870 is an FDA 510(k) clearance for URETERAL STANT SET, manufactured by Van-Tec, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K820870 · Van-Tec, Inc. · Gastroenterology & Urology device
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Apr 1982
Decision
28d
Days
Class 2
Risk

K820870 is an FDA 510(k) clearance for the URETERAL STANT SET. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982 after a review of 28 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 Van-Tec, Inc. devices

FDA 510(k) Submission Details - K820870

510(k) Number K820870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date April 26, 1982
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
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 104
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K820870.
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
SURGITEK URINARY DIVERSION STENT
K800109 · Medical Engineering Corp. · Feb 1980
SURGITEK DOUBLE J URETEROL STENT
K781641 · Medical Engineering Corp. · Dec 1978