# K201134: Arthrex NanoScope System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 4, 2020 after 129 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: 6 generations back to K950862 (1995). 14 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190645: Arthrex NanoScope System, Arthrex, Inc. (2019) Summary page 4.
- K180766: Endiscope, Endiscope Cervical, Elliquence, LLC (2018) Summary page 4.

## Cited in the summary but kept off the family tree
- K180299: ACUVUE OASYS (senofilcon A) with Photochromic Additive, Johnson & Johnson Vision Care, Inc. (2018). Our reading of the summary gave K180299, FDA’s number for ACUVUE OASYS (senofilcon A) with Photochromic Additive (Johnson & Johnson Vision Care, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Elliquence Endiscope Cervical”. Kept off the family tree. Summary page 4.

## Most influential descendants
- 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
- K252640: VereSee Optical Veres Needle and Endoscopic Camera (2025), 1 descendant 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 diagnostic and surgical procedures, including but not limited to: orthopedic, spine, 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/K201134
Methodology: https://510kreport.com/methodology