RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm— 510(k) K213444

Name: FDA 510(k) clearance K213444
Creator: U.S. Food and Drug Administration
Published: 2022-03-17

Substantially Equivalent

Ureteral Stent Company

FDA 510(k) clearance K213444 for RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm, Substantially Equivalent on 2022-03-17. Applicant: Ureteral Stent Company. Device class: 2.

Clearance details

Applicant: Ureteral Stent Company
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2021-10-25
Decision date: 2022-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chagrin Falls, OH, US

Download summary PDF View on FDA.gov ↗

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K251890 — Disposable Ureteral Stents2026-02-20
K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

More clearances from Ureteral Stent Company

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K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm2024-03-22

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.