FDA 510(k)

Sphincterotome / short-wire compatible, Sterile Sphincterotome

Número K: K210934 · 2021-12-01

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2021-12-01

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sphincterotome / short-wire compatible, Sterile Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K210934. 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 Sphincterotome / short-wire compatible, Sterile Sphincterotome?

Sphincterotome / short-wire compatible, Sterile Sphincterotome is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K210934.

When did Sphincterotome / short-wire compatible, Sterile Sphincterotome receive FDA 510(k) clearance?

Sphincterotome / short-wire compatible, Sterile Sphincterotome received FDA 510(k) clearance on 2021-12-01, under 510(k) number K210934.

Who is the listed applicant for Sphincterotome / short-wire compatible, Sterile Sphincterotome?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sphincterotome / short-wire compatible, Sterile Sphincterotome?

The FDA product code for Sphincterotome / short-wire compatible, Sterile Sphincterotome is KNS.

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