# K243008: Arthrex NanoScope System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 22, 2025 after 118 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: 20 generations back to K930667 (1994). 104 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201134: Arthrex NanoScope System, Arthrex, Inc. (2020) Summary page 5.
- K210088: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes, Stryker (2021) Summary page 5.

## Most influential descendants
- K252640: VereSee Optical Veres Needle and Endoscopic Camera (2025), 1 descendant of its own
- K250728: Arthrex Synergy Vision Endoscopic Imaging System (2025), 1 descendant of its own
- K261139: VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) (2026), 0 descendants of its own
- K251994: Arthrex Synergy Vision Imaging System (2025), 0 descendants of its own

## Indications for use
The Arthrex NanoScope 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, and urology. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.

Source page: https://510kreport.com/device/K243008
Methodology: https://510kreport.com/methodology