FDA 510(k)

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

Número K: K232920 · 2024-03-22

Data da decisão2024-03-22

Código do produtoFAD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is the device name listed in this FDA 510(k) record. The listed applicant is Ureteral Stent Company. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K232920. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Ureteral Stent Company. The 510(k) number is K232920.

When did RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm receive FDA 510(k) clearance?

RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm received FDA 510(k) clearance on 2024-03-22, under 510(k) number K232920.

Who is the listed applicant for RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm?

The FDA 510(k) record lists Ureteral Stent Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm?

The FDA product code for RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is FAD.

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Outros registros que listam Ureteral Stent Company como candidato(a)

K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

Dispositivos Relacionados (Código: FAD)

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