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FUJIFILM Processor EP-8000

by Fujifilm Corporation

510(k) K261880

FUJIFILM Processor EP-8000 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K261880 on 2 Jul 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK261880 Date2 Jul 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FET
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Devices cleared under K261880

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K261880
UDI-DISize and differences
FUJIFILM EP-8000
FUJIFILM CORPORATION
EP-800004547410513790 —On the market
FUJIFILM EW10-VM01
FUJIFILM CORPORATION
EW10-VM0104547410433975 —On the market
FUJIFILM PB-30
FUJIFILM CORPORATION
PB-3004547410332063 —On the market

Similar devices

Other devices filed under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Other devices from Fujifilm Corporation

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