Intracept Intraosseous Nerve Ablation System
FDA 510(k) clearance K222281 · decided 2022-10-26
Clearance details
- K-number
- K222281
- Device name
- Intracept Intraosseous Nerve Ablation System
- Applicant
- Relievant Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-29
- Decision date
- 2022-10-26
- Days to decision
- 89 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
| Record | Firm | Date |
|---|---|---|
| Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035 recall (Z-2694-2026) | Boston Scientific Neuromodulation Corporation | 2026-07-08 |