Cleared Traditional

K232920 - RELIEF™ Ureteral Stent Kit (FDA 510(k) Clearance)

Also includes:
Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit Model: RS-002 - 6 Fr x 26cm

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232920 · Ureteral Stent Company · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
185d
Days
Class 2
Risk

K232920 is an FDA 510(k) clearance for the RELIEF™ Ureteral Stent Kit. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Ureteral Stent Company (Chagrin Falls, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 185 days - an extended review 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: 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 Ureteral Stent Company devices

Submission Details

510(k) Number K232920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2023
Decision Date March 22, 2024
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 130d · This submission: 185d
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 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K232920.
Disposable Ureteral Stents
K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2026
Endura™ Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Disposable ureteral stent
K243830 · Shenzhen Trious Medical Technology Co., Ltd. · May 2025
Percuflex Ureteral Stent
K250824 · Boston Scientific Corporation · Apr 2025
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K211934 · Boston Scientific Corporation · Nov 2022