510(k) K250213
- Device
- OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
- Applicant
- Stryker Instruments
- 510(k) number
- K250213
- Product code
- GXI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-15
- Date received
- 2025-01-24
- Regulation
- 882.4725
- Classification name
- Probe, Radiofrequency Lesion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Dayana Manganese
- Address
- 1941 Stryker Way Portage MI US 49002 49002
FDA Registration Numbers
- 3013111980
- 1450662
- 1221485
- 9616662
- 3004617090
- 2133786
- 3021008900
- 3043527620
- 2183744
- 3012536737
- 1644312
- 3006630150
- 2032521
- 3009241989
- 1313525
- 3009823392
- 1225687
- 1721676
- 3009766315
- 3016438686
- 3006950086
- 3033589330
- 8043398
- 9611612
- 3013302242
- 8010177
- 3030733800
- 3005334138
- 1627487
- 1030489
- 3015173212
- 9616693
- 3007695959
- 1928237
- 3009732568
- 3008998256
- 3010966701
- 1319639
- 3005160949
- 9611665
- 3003477135
- 3003120897
- 3020968442
- 3007997036
- 3011270181
- 3008102042
- 2030624
- 3008534770
- 1720929
- 3004762958
- 3005941719
- 3008559295
- 3015924373
- 1222773
- 1000632857
- 3007221462
- 3010273872
- 3010034260
- 1643817
- 2029275
- 2124215
- 9680001
- 9680425
- 2182979
- 3008837339
- 3007029079
- 3010126772
- 1224960
- 1721983
- 3004785273
- 3029990829
- 1316297
- 3017423051
- 3016678045
- 1526711
- 2182269
- 3015967359
- 1000121056
- 1643059
- 1920664
- 3015309643
- 3003365815
- 1721504
- 3018094310
- 3015443199
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code GXI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | 2026-04-16 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026-02-13 |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025-08-15 |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | 2025-05-27 |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-10-26 |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-03-11 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020-12-22 |
| K190259 | Vesta RF Cannula | Biomerics | 2020-02-07 |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020-01-24 |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | 2019-05-03 |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019-03-08 |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | 2019-03-08 |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018-09-14 |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017-08-09 |