# K190804: HydroCision TenJet Device

- Pathway: 510(k) (Traditional)
- Applicant: Hydrocision, Inc.
- Decided: Jun 5, 2019 after 68 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: 4 generations back to K002764 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041233: Arthrojet XT, Hydrocision, Inc. (2004) Summary page 5.

## Indications for use
HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

Source page: https://510kreport.com/device/K190804
Methodology: https://510kreport.com/methodology