# K033573: Linvatec 10K Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Feb 11, 2004 after 90 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: 2 generations back to K902722 (1990). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961590: Apex Universal Irrigation System & Two-Connection Tubing Set, Linvatec Corp. (1996) Summary page 2.
- K961224: Hydro-Flex LI Laparoscopic Irrigation System, Davol Inc., Sub. C. R. Bard, Inc. (1996) Summary page 2.

## Most influential descendants
- K063326: Conmed Linvatec 24K Irrigation System (2007), 1 descendant of its own
- K182882: CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control (2018), 0 descendants of its own

## Indications for use
The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K033573
Methodology: https://510kreport.com/methodology