# K944210: Arthroscope Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Feb 14, 1995 after 169 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Mar 7, 2011 · Not classified · Z-1927-2011: Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.
- Dec 1, 2008 · Not classified · Z-0868-2009: Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
- Oct 1, 2008 · Not classified · Z-0652-2009: Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.

Source page: https://510kreport.com/device/K944210
Methodology: https://510kreport.com/methodology