FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeurAxis IB-Stim (01-1020)
K Number: K241533
·
Decision Oct 30, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
3
Review Days
153
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Basic Information
- Device Name
- NeurAxis IB-Stim (01-1020)
- K Number
- K241533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5340
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuraxis
- Date Received
- May 30, 2024
- Decision Date
- October 30, 2024
- Product Code
- QHH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| QHH | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | FDA class 2 | Gastroenterology, Urology |
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