FDA 510(k)

Inno-Switch™ Laparoscopic Instruments

Número K: K252535 · 2026-08-25

Data da decisão2026-08-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Inno-Switch™ Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Surgical Corporation. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K252535. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Inno-Switch™ Laparoscopic Instruments?

Inno-Switch™ Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K252535.

When did Inno-Switch™ Laparoscopic Instruments receive FDA 510(k) clearance?

Inno-Switch™ Laparoscopic Instruments received FDA 510(k) clearance on 2026-08-25, under 510(k) number K252535.

Who is the listed applicant for Inno-Switch™ Laparoscopic Instruments?

The FDA 510(k) record lists Taiwan Surgical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inno-Switch™ Laparoscopic Instruments?

The FDA product code for Inno-Switch™ Laparoscopic Instruments is GEI.

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Fonte oficial

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