Cleared Traditional

K852389 - URETERAL STENT

K852389 is the FDA 510(k) clearance for URETERAL STENT by American Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K852389 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Sep 1985
Decision
92d
Days
Class 2
Risk

K852389 is an FDA 510(k) clearance for the URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 92 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 American Medical Systems, Inc. devices

Submission Details

510(k) Number K852389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date September 05, 1985
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
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 74
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K852389.
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
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · Mentor Corp. · Jul 1985
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985