Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base— 510(k) K172644
Substantially EquivalentStimwave Technologies Incorporated
FDA 510(k) clearance K172644 for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base, Substantially Equivalent on 2017-11-03. Applicant: Stimwave Technologies Incorporated.
Clearance details
- Applicant
- Stimwave Technologies Incorporated
- Product code
- Code GZB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pompano Beach, FL, US
Adverse events under product code GZB
product code GZB- Death
- 4
- Injury
- 1,879
- Other
- 2
- Total
- 1,885
Source: openFDA MAUDE database, through . 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.