# K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: Aug 3, 1999 after 41 days
- Product code: GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered)
- Device class: 2
- Regulation: 21 CFR 880.6740
- 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 K934094 (1994). 3 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932626: Cabot Medical Surgiflex (R) Suction-Irrigation Prob, Cabot Medical Corp. (1994) Summary page 1.
- K961492: Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010, Davol Inc., Sub. C. R. Bard, Inc. (1996) Summary page 1.
- K934094: Stryker Laparoscopic Suction Irrigator, Stryker Corp. (1994) Summary page 1.

## Most influential descendants
- 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
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own

## Indications for use
Circon Corporation’s Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon’s Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

Source page: https://510kreport.com/device/K992126
Methodology: https://510kreport.com/methodology