Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

K-Number: K243260 · 2025-04-11

ApplicantFujifilm Corporation
Decision Date2025-04-11
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-04-11 under approval number K243260. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Fujifilm Corporation. The 510(k) number is K243260.

When was FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R approved by the FDA?

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R received FDA 510(k) clearance on 2025-04-11, under approval number K243260.

What company makes FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?

The FDA product code for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is FET.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

View all 62 devices →

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation

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.

↑