K200482
Substantially EquivalentStimRouter Neuromodulation System
- Applicant
- Bioness, Inc.
- Product code
- GZF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Valencia, CA, US
Adverse events under product code GZF
product code GZF- Death
- 10
- Injury
- 2,410
- Other
- 1
- Total
- 2,421
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.