FDA 510(k)

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

Número K: K253137 · 2026-06-16

Data da decisão2026-06-16

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253137. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Fujifilm Corporation. The 510(k) number is K253137.

When did FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253137.

Who is the listed applicant for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

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

What is the FDA product code for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

The FDA product code for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T is EOQ.

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