FDA 510(k)

Electrohydraulic Lithotriptor (TCS-B3-II)

Número K: K242888 · 2025-03-21

RequerenteGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Data da decisão2025-03-21

Código do produtoFFK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electrohydraulic Lithotriptor (TCS-B3-II) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K242888. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Electrohydraulic Lithotriptor (TCS-B3-II)?

Electrohydraulic Lithotriptor (TCS-B3-II) is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K242888.

When did Electrohydraulic Lithotriptor (TCS-B3-II) receive FDA 510(k) clearance?

Electrohydraulic Lithotriptor (TCS-B3-II) received FDA 510(k) clearance on 2025-03-21, under 510(k) number K242888.

Who is the listed applicant for Electrohydraulic Lithotriptor (TCS-B3-II)?

The FDA 510(k) record lists Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrohydraulic Lithotriptor (TCS-B3-II)?

The FDA product code for Electrohydraulic Lithotriptor (TCS-B3-II) is FFK.

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Outros registros que listam Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. como candidato(a)

K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)K253633Holmium Laser Therapeutic Apparatus (HZ-40)K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)K252771Sistema de Laser de Holmium (Potent HP90); Sistema de Laser de Holmium (Potent HP100); Sistema de Laser de Holmium (Potent HP9120); Sistema de Laser de Holmium (Potent HP140); Sistema de Laser de Holmium (Potent HP150)K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: FFK)

K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K162119UreTron PF Series ProbeMed-Sonics Corp.K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp.

Fonte oficial

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