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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K243260.

When did FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R receive FDA 510(k) clearance?

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

Who is the listed applicant for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?

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 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 records listing Fujifilm Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCK260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TK254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)

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Related Devices (Code: FET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAOlympus Corporations of the Americas

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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