# K983561: Fujinon Evl-F Video Laproscope

- Pathway: 510(k) (Special)
- Applicant: Fujinon, Inc.
- Decided: Dec 16, 1998 after 64 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162836: FUJIFILM Surgical System (2017), 8 descendants of its own
- 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

## Indications for use
The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy plerodesis, thoracoscopy pleurodesis.

Source page: https://510kreport.com/device/K983561
Methodology: https://510kreport.com/methodology