# K162836: FUJIFILM Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm New Development U.S.A., Inc.
- Decided: Mar 13, 2017 after 153 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 32 ancestors in all.
8 later devices descend from it; 2 cite it directly.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983561: Fujinon Evl-F Video Laproscope, Fujinon, Inc. (1998) Summary page 4.
- K140149: Epx-4440HD Digital Video Processor, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

## Most influential descendants
- K192918: Video Laparoscope, Video Processor, Light Source (2020), 6 descendants of its own
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (2021), 3 descendants of its own
- K250268: HyperSnap Surgical System (HSS) (2025), 1 descendant of its own
- K202130: FUJIFILM Video Laparoscope (2020), 1 descendant of its own
- K253984: Instrument Exit Point on Touch Surgery™ Aide (2026), 0 descendants of its own

## Indications for use
The FUJIFILM Surgical System includes a laparoscope, video processor and light source and is intended to be used with a monitor, hand instruments, electrosurgical unit, and other ancillary equipment for minimally invasive laparoscopic observation, diagnosis and treatment in general abdominal and gynecologic areas.

Source page: https://510kreport.com/device/K162836
Methodology: https://510kreport.com/methodology