K232920

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

510(k) number
K232920
Device name
RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Applicant
Ureteral Stent Company OH · US
Product code
FAD — Stent, Ureteral
Decision date
2024-03-22
Date received
2023-09-19
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
510(k) Summary (official FDA PDF): K232920.pdf
Official FDA record: K232920
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.