Cleared Traditional

K854908 - UROFLEX

K854908 is the FDA 510(k) clearance for UROFLEX by Angiomed U.S., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K854908 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Mar 1986
Decision
95d
Days
Class 2
Risk

K854908 is an FDA 510(k) clearance for the UROFLEX. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 95 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.

View all Angiomed U.S., Inc. devices

Submission Details

510(k) Number K854908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date March 14, 1986
Days to Decision 95 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
35d faster than avg
Panel avg: 130d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K854908.
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
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · Mentor Corp. · Mar 1986
CURITY URETERAL STENT
K854862 · The Kendal Co. · Feb 1986
URETERAL STENT
K852389 · American Medical Systems, Inc. · Sep 1985