7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application— 510(k) K192945

Substantially Equivalent

7D Surgical, Inc.

FDA 510(k) clearance K192945 for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, Substantially Equivalent on 2019-11-27. Applicant: 7D Surgical, Inc..

Clearance details

Applicant: 7D Surgical, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2019-10-18
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.