FDA 510(k)

Sphincterotome

Número K: K260962 · 2026-05-21

Data da decisão2026-05-21

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sphincterotome 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 2026-05-21 under 510(k) number K260962. 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?

Sphincterotome is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K260962.

When did Sphincterotome receive FDA 510(k) clearance?

Sphincterotome received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260962.

Who is the listed applicant for Sphincterotome?

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 Sphincterotome?

The FDA product code for Sphincterotome is KNS.

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Fonte oficial

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