# K153367: S698 Symbioz flow

- Pathway: 510(k) (Traditional)
- Applicant: Sopro - Acteon Group
- Decided: Jun 17, 2016 after 207 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.

Source page: https://510kreport.com/device/K153367
Methodology: https://510kreport.com/methodology