# K233115: Hawkeye Control Unit with Eyas Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: E Surgical, LLC
- Decided: Feb 6, 2024 after 132 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 5.

## Indications for use
The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.

Source page: https://510kreport.com/device/K233115
Methodology: https://510kreport.com/methodology