Cleared Traditional

K871667 - URETERAL STENT

K871667 is an FDA 510(k) clearance for URETERAL STENT, manufactured by Penn Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K871667 · Penn Medical Devices, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
43d
Days
Class 2
Risk

K871667 is an FDA 510(k) clearance for the URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Penn Medical Devices, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on June 10, 1987 after a review of 43 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 Penn Medical Devices, Inc. devices

FDA 510(k) Submission Details - K871667

510(k) Number K871667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date June 10, 1987
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 94
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K871667.
MENTOR UNISTENT URETERAL STENT SET
K875038 · Mentor Corp. · Mar 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · Mentor Corp. · Feb 1988
SURGITEK INFUSION STENT SYSTEM*
K872353 · Surgitek · Sep 1987
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · Van-Tec, Inc. · Mar 1987
METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.
K863492 · Surgitek · Dec 1986
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · Mentor Corp. · Sep 1986