StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
FDA 510(k) clearance K142432 · decided 2015-02-20
Clearance details
- K-number
- K142432
- Device name
- StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
- Applicant
- Bioness, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-29
- Decision date
- 2015-02-20
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GZF
- Device class
- 2
- Regulation number
- 882.5870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.