# K070783: Sopro Model 640 Laparoscopic Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Dec 13, 2007 after 267 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 K031014 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031014: HI-Flo Therme Pneu 45, Wisap #7083, 7083V, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (2003) Summary page 1.

## Most influential descendants
- K090652: Alpha Duo Lap Insufflator (2009), 0 descendants of its own

## Indications for use
The SOPRO 640 Laparoscopic Insufflator may only be used by qualified physicians for building up a pneumoperitoneum with C02 Gas for diagnostic or operative Laparoscopy.

Source page: https://510kreport.com/device/K070783
Methodology: https://510kreport.com/methodology