# K042454: Stryker Cassette Pump

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Dec 9, 2004 after 90 days
- Product code: GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954726 (1995). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954726: Stryker Strykeflow Suction Irrigator (Modification), Stryker Endoscopy (1995) Summary page 1.
- K003790: Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005, Davol, Inc. (2000) Summary page 1.

## Most influential descendants
- K122619: Epix Irrigation Pump, Epix Suction Irrigation Tubing Set (2012), 3 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own
- K201355: Endomat Select, IBS Shaver Software, License (2020), 1 descendant of its own
- K261706: Endomat Select (UP220) (2026), 0 descendants of its own

## Recalls of this device
- Jun 8, 2026 · Class II · Z-2864-2026: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Jun 8, 2026 · Class II · Z-2862-2026: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Jun 8, 2026 · Class II · Z-2863-2026: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Nov 17, 2017 · Class II · Z-0836-2018: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- Nov 18, 2005 · Not classified · Z-0279-06: Devices for which sterility may be compromised as evidenced by a crack in the package.

## Indications for use
The Stryker Cassette Pump Is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.

Source page: https://510kreport.com/device/K042454
Methodology: https://510kreport.com/methodology