# K250728: Arthrex Synergy Vision Endoscopic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 5, 2025 after 55 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: 24 generations back to K930667 (1994). 175 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241361: Arthrex Synergy Vision Endoscopic Imaging System, Arthrex, Inc. (2024) Summary page 6.
- K243008: Arthrex NanoScope System, Arthrex, Inc. (2025) Summary page 6.

## Most influential descendants
- K251994: Arthrex Synergy Vision Imaging System (2025), 0 descendants of its own

## Indications for use
The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

Source page: https://510kreport.com/device/K250728
Methodology: https://510kreport.com/methodology