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FDA 510(k)

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000

K-Number: K244017 · 2025-06-13

ApplicantFujifilm Corporation
Decision Date2025-06-13
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-06-13 under approval number K244017. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000?

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 is a medical device that received FDA 510(k) clearance on 2025-06-13. It is manufactured by Fujifilm Corporation. The 510(k) number is K244017.

When was FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 approved by the FDA?

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 received FDA 510(k) clearance on 2025-06-13, under approval number K244017.

What company makes FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000?

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000?

The FDA product code for FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 is EOQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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