510(k) K222281 ยท GXI Probe, Radiofrequency Lesion
Intracept Intraosseous Nerve Ablation System
| Applicant | Relievant Medsystems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 26, 2022 |
| Received | Jul 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2026 | Boston Scientific Neuromodulation Corporation Intracept Access Instruments, Description/REF:
INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035,
INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU,
INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045,
INTRACEPT ACCE Open, Classified |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.