# K191345: Pegasus System

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: Jul 17, 2019 after 58 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K833587 (1983). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162475: mi-eye 2, mi-eye 2 monitor, Trice Medical (2016) Summary page 4.

## Indications for use
The Pegasus System 1s indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Source page: https://510kreport.com/device/K191345
Methodology: https://510kreport.com/methodology