# K961590: Apex Universal Irrigation System & Two-Connection Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Oct 8, 1996 after 167 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033573: Linvatec 10K Irrigation System (2004), 2 descendants of its own
- 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

## Recalls of this device
- May 30, 2013 · Class II · Z-1681-2013: Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the

Source page: https://510kreport.com/device/K961590
Methodology: https://510kreport.com/methodology