Epione— 510(k) K211645

Substantially Equivalent

Quantum Surgical Sas

FDA 510(k) clearance K211645 for Epione, Substantially Equivalent on 2022-02-24. Applicant: Quantum Surgical Sas.

Clearance details

Applicant: Quantum Surgical Sas
Product code: Code JAK
Advisory panel: Radiology
Date received: 2021-05-28
Decision date: 2022-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.