# K260414: “Tech-Image” Video Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Tech-Image CO., LTD.
- Decided: Jun 10, 2026 after 121 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: 7 generations back to K950862 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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.
- K203226: Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM, Richard Wolf Medical Instruments Corporation (2021) Summary page 5.

## Indications for use
The “Tech-Image” Video Endoscope System is intended to be used as a single-use endoscopic video camera to provide visualization of the interior of the body’s internal anatomy during various diagnostic and surgical endoscopic procedures. These applications include, but are not limited to: general surgery and minimally invasive surgery (e.g., orthopedic, spine, laparoscopic, and plastic surgical procedures).

Source page: https://510kreport.com/device/K260414
Methodology: https://510kreport.com/methodology