Cleared Traditional

RELIEF? Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF? Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

K232920 · Ureteral Stent Company · Gastroenterology & Urology
Mar 2024
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K232920 is an FDA 510(k) clearance for the RELIEF? Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF? Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Ureteral Stent Company (Chagrin Falls, US). The FDA issued a Cleared decision on March 22, 2024, 185 days after receiving the submission on September 19, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K232920 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FAD — Stent, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4620

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