# K980599: Ntech Arthroscope

- Pathway: 510(k) (Traditional)
- Applicant: N-Tech Endoscopy, Inc.
- Decided: Apr 15, 1998 after 57 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Operative and Diagnostic Arthroscopy for visual imiging and light transmission to the operative area. The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.

Source page: https://510kreport.com/device/K980599
Methodology: https://510kreport.com/methodology