SureTune4 Software
FDA 510(k) clearance DEN210003 · decided 2021-08-23
Clearance details
- K-number
- DEN210003
- Device name
- SureTune4 Software
- Applicant
- Medtronic Neuromodulation
- Decision
- Unknown
- Date received
- 2021-02-03
- Decision date
- 2021-08-23
- Days to decision
- 201 days
- Clearance type
- Direct
- Product code
- QQC
- Device class
- 2
- Regulation number
- 882.5855
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| InterStim Therapy System, Verify Evaluation System (P080025/S337) | Medtronic Neuromodulation | 2025-12-23 |
| InterStim Therapy System, Verify Evaluation System (P970004/S442) | Medtronic Neuromodulation | 2025-12-23 |
| Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve (P840001/S616) | Medtronic Neuromodulation | 2025-12-22 |
| InterStim Therapy System; Verify Evaluation System (P970004/S441) | Medtronic Neuromodulation | 2025-12-22 |
| InterStim Therapy System; Verify Evaluation System (P080025/S336) | Medtronic Neuromodulation | 2025-12-22 |
| Medtronic Altaviva System (P240011/S004) | Medtronic Neuromodulation | 2025-12-19 |
| Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (P840001/S614) | Medtronic Neuromodulation | 2025-12-18 |
| InterStim Therapy System, Verify Evaluation System (P080025/S334) | Medtronic Neuromodulation | 2025-11-26 |