PLASMA EDGE System— 510(k) K240504

Substantially Equivalent

Lamidey Noury Medical

FDA 510(k) clearance K240504 for PLASMA EDGE System, Substantially Equivalent on 2024-06-12. Applicant: Lamidey Noury Medical.

Clearance details

Applicant: Lamidey Noury Medical
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2024-02-21
Decision date: 2024-06-12
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.