S698 Symbioz flow— 510(k) K153367

Substantially Equivalent

Sopro - Acteon Group

FDA 510(k) clearance K153367 for S698 Symbioz flow, Substantially Equivalent on 2016-06-17. Applicant: Sopro - Acteon Group.

Clearance details

Applicant: Sopro - Acteon Group
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2015-11-23
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Ciotat, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.