# K020083: Tuta Healthcare Arthroscopy Flushing Set, Model 80.601

- Pathway: 510(k) (Traditional)
- Applicant: Tuta Healthcare Pty Limited
- Decided: Feb 12, 2002 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: 1 generation back to K883300 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883300: Irrigation Set, Edwards Orthopaedics Div., Baxter Healthcare Corp. (1988) Summary page 1.

## Indications for use
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid-management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).

Source page: https://510kreport.com/device/K020083
Methodology: https://510kreport.com/methodology