# K961224: Hydro-Flex LI Laparoscopic Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: May 16, 1996 after 48 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902722 (1990). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902722: Bard Laparoscopic Irrigator Pump System, Davol, Inc. (1990) Summary page 1.
- K911493: Laparoscopic Irrigation Pump, United States Endoscopy Group, Inc. (1991) Summary page 1.
- K911484: Laparoscopic Suction Irrigation Tubing Set, United States Endoscopy Group, Inc. (1991) Summary page 1.
- K933873: Concept Universal Pump System, Linvatec Corp. (1994) Summary page 1.

## 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

## Indications for use
The HydroFlex LI System is designed to provide controlled irrigation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

Source page: https://510kreport.com/device/K961224
Methodology: https://510kreport.com/methodology