The EPAD 2 System— 510(k) K182542

Substantially Equivalent

Safeop Surgical, Inc.

FDA 510(k) clearance K182542 for The EPAD 2 System, Substantially Equivalent on 2019-02-22. Applicant: Safeop Surgical, Inc..

Clearance details

Applicant: Safeop Surgical, Inc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2018-09-17
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.