FDA 510(k)

“Tech-Image” Video Endoscope System

Número K: K260414 · 2026-06-10

Data da decisão2026-06-10

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

“Tech-Image” Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Image CO., LTD.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K260414. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the “Tech-Image” Video Endoscope System?

“Tech-Image” Video Endoscope System is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Tech-Image CO., LTD.. The 510(k) number is K260414.

When did “Tech-Image” Video Endoscope System receive FDA 510(k) clearance?

“Tech-Image” Video Endoscope System received FDA 510(k) clearance on 2026-06-10, under 510(k) number K260414.

Who is the listed applicant for “Tech-Image” Video Endoscope System?

The FDA 510(k) record lists Tech-Image CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “Tech-Image” Video Endoscope System?

The FDA product code for “Tech-Image” Video Endoscope System is GCJ.

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