# K190645: Arthrex NanoScope System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 5, 2019 after 114 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: 5 generations back to K950862 (1995). 6 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153218: Arthrex Synergy UHD4 System, Arthrex, Inc. (2016) Summary page 4.

## Most influential descendants
- K201134: Arthrex NanoScope System (2020), 11 descendants of its own
- K243008: Arthrex NanoScope System (2025), 4 descendants of its own
- K223759: Arthrex SynergyID Endoscopic Imaging System (2023), 4 descendants of its own
- K233451: Arthrex Synergy Vision Endoscopic Imaging System (2024), 3 descendants of its own
- K241361: Arthrex Synergy Vision Endoscopic Imaging System (2024), 2 descendants of its own

## Indications for use
The Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

Source page: https://510kreport.com/device/K190645
Methodology: https://510kreport.com/methodology