Cleared Traditional

K854862 - CURITY URETERAL STENT

K854862 is an FDA 510(k) clearance for CURITY URETERAL STENT, manufactured by The Kendal Co.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K854862 · The Kendal Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
67d
Days
Class 2
Risk

K854862 is an FDA 510(k) clearance for the CURITY URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 67 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 The Kendal Co. devices

FDA 510(k) Submission Details - K854862

510(k) Number K854862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1985
Decision Date February 10, 1986
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
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 95
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K854862.
MARDIS DANGLER URETERAL STENT SET
K860267 · Van-Tec, Inc. · Apr 1986
UROFLEX
K854908 · Angiomed U.S., Inc. · Mar 1986
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · Mentor Corp. · Mar 1986
URETERAL STENT
K852389 · American Medical Systems, Inc. · Sep 1985
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · Mentor Corp. · Jul 1985
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985