# K244017: FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Jun 13, 2025 after 168 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 40 ancestors in all.
No later device cites it as a predicate yet.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220957: FUJIFILM Endoscope Model EB-710P, Fujifilm Corporaton (2022) Summary page 5.
- K163675: Processor VP-7000, Light Source BL-7000, Fujifilm Medical System U.S.A., Inc. (2017) Summary page 5.

## Indications for use
a. Endoscope Model EB-710P Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes. b. Processor EP-8000 The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It is used for endoscopic observation, diagnosis and treatment.

Source page: https://510kreport.com/device/K244017
Methodology: https://510kreport.com/methodology