# K961492: Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: May 15, 1996 after 27 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Endo-Flo Irrigation System: named in the summary without a submission number
- (no number) StrykeFlow Disposable Suction Irrigator: named in the summary without a submission number

## Most influential descendants
- K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System (1999), 30 descendants of its own
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own

## Recalls of this device
- Jun 7, 2022 · Class II · Z-1304-2022: The product is not able to provide irrigation.
- Jun 7, 2022 · Class II · Z-1305-2022: The product is not able to provide irrigation.

## Indications for use
The Hydro-Surg Irrigator is designed to be used in conjunction with a laparoscopic probe handle and tip to provide controlled powered irrigation/aspiration during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

Source page: https://510kreport.com/device/K961492
Methodology: https://510kreport.com/methodology