# K973432: Surgiflator-30

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Dec 9, 1997 after 90 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.
No later device cites it as a predicate yet.
0 of 3 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.
- (no number) KSEA Thermoflator, Model 26 4320 20: named in the summary without a submission number

## Indications for use
To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Source page: https://510kreport.com/device/K973432
Methodology: https://510kreport.com/methodology