SandShark Injectable Anchor (SIA) System— 510(k) K191466

Substantially Equivalent

Stimwave Technologies, Inc.

FDA 510(k) clearance K191466 for SandShark Injectable Anchor (SIA) System, Substantially Equivalent on 2019-11-07. Applicant: Stimwave Technologies, Inc..

Clearance details

Applicant: Stimwave Technologies, Inc.
Product code: Code GZB
Advisory panel: Neurology
Date received: 2019-06-03
Decision date: 2019-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.