Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge— 510(k) K213135

Substantially Equivalent

Chirurgie Innovation

FDA 510(k) clearance K213135 for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge, Substantially Equivalent on 2022-03-02. Applicant: Chirurgie Innovation.

Clearance details

Applicant: Chirurgie Innovation
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-27
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Verrières Le Buisson, 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.