7D Surgical System - Percutaneous Application (7D Flash Frame)— 510(k) K220522

Substantially Equivalent

7D Surgical

FDA 510(k) clearance K220522 for 7D Surgical System - Percutaneous Application (7D Flash Frame), Substantially Equivalent on 2022-05-20. Applicant: 7D Surgical.

Clearance details

Applicant: 7D Surgical
Product code: Code OLO
Advisory panel: Neurology
Date received: 2022-02-23
Decision date: 2022-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.