Plasma Edge System— 510(k) K163090

Substantially Equivalent

Chirurgie Innovation

FDA 510(k) clearance K163090 for Plasma Edge System, Substantially Equivalent on 2017-05-23. Applicant: Chirurgie Innovation.

Clearance details

Applicant: Chirurgie Innovation
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2016-11-04
Decision date: 2017-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Massy, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.