# K003790: Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Dec 22, 2000 after 14 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices 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.

## Most influential descendants
- K042454: Stryker Cassette Pump (2004), 4 descendants of its own
- 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 27, 2022 · Class II · Z-1457-2022: The device may potentially cause a fire, leading to a safety risk.

Source page: https://510kreport.com/device/K003790
Methodology: https://510kreport.com/methodology