# K212556: mi-eye 3 needlescope with cannula, mi-tablet 3

- Pathway: 510(k) (Special)
- Applicant: Trice Medical, Inc.
- Decided: Sep 15, 2021 after 33 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 mi-eye 3 needlescopeTM with cannula, mi-eye tablet 3TM is indicated for use in 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/K212556
Methodology: https://510kreport.com/methodology