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

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.

Clearance details

Applicant: Ureteral Stent Company
Product code: Code FAD
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

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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.