Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
FDA 510(k) clearance K180369 · decided 2018-09-14
Clearance details
- K-number
- K180369
- Device name
- Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
- Applicant
- Relievant Medsystems
- Decision
- Substantially Equivalent
- Date received
- 2018-02-12
- Decision date
- 2018-09-14
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.