# K981859: Surgiflator-20 Ecu

- Pathway: 510(k) (Special)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Jun 26, 1998 after 30 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950035 (1996). 2 ancestors in all.
31 later devices descend from it; 1 cites 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)
- K955791: Surgiflator-20 Pim, W.O.M. World of Medicine GmbH (1996) Summary page 1.

## Most influential descendants
- K990443: Arthro-Surgimat-2000 Ecu (1999), 30 descendants of its own
- K030402: Arthroscopy Pump, Model A107 (2003), 29 descendants of its own
- K062380: Flosimple Arthroscopy Pump A120 (2006), 15 descendants of its own
- K112642: Aquilex Fluid Control System H112 (2012), 14 descendants of its own
- K123732: Hysteroscopy Pump HM6 (2013), 6 descendants of its own

## Indications for use
intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic visualization

Source page: https://510kreport.com/device/K981859
Methodology: https://510kreport.com/methodology