# K955791: Surgiflator-20 Pim

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Dec 17, 1996 after 361 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: 1 generation back to K950035 (1996). 1 ancestor in all.
33 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950035: Surgiflator 20, W.O.M. GmbH (1996). Cleared while this submission was under review Summary page 1.
- (no number) Snowden-Pencer High Flow Insufflator, Model 89-8600: named in the summary without a submission number
- (no number) Snowden-Pencer High Flow Insufflator, Model SP 88-9700: named in the summary without a submission number

## Most influential descendants
- K981859: Surgiflator-20 Ecu (1998), 31 descendants of its own
- 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

## Indications for use
The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO, to enable laparoscopic procedures.

Source page: https://510kreport.com/device/K955791
Methodology: https://510kreport.com/methodology