FDA 510(k)

Optimos™ Cystotome

Número K: K223256 · 2023-04-05

Data da decisão2023-04-05

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optimos™ Cystotome is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K223256. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optimos™ Cystotome?

Optimos™ Cystotome is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223256.

When did Optimos™ Cystotome receive FDA 510(k) clearance?

Optimos™ Cystotome received FDA 510(k) clearance on 2023-04-05, under 510(k) number K223256.

Who is the listed applicant for Optimos™ Cystotome?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optimos™ Cystotome?

The FDA product code for Optimos™ Cystotome is KNS.

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Outros registros que listam Taewoong Medical Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Fonte oficial

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