FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StimTrial Neuromodulation System
K Number: K243782
·
Decision Jul 16, 2025
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
23
Applicant Total
5
Review Days
219
Basic Information
- Device Name
- StimTrial Neuromodulation System
- K Number
- K243782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioventus, LLC
- Date Received
- December 9, 2024
- Decision Date
- July 16, 2025
- Product Code
- GZF
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
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Other Clearances by Bioventus, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K243678 | TalisMann Neuromodulation System | Jul 3, 2025 | Substantially Equivalent |
| K233368 | Allograft Delivery Device (OFAC-C) | Jun 25, 2024 | Substantially Equivalent |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Dec 5, 2023 | Substantially Equivalent |
| K162860 | MCS Bone Graft | Feb 13, 2017 | Substantially Equivalent |