FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EARP Nerve Cuff Electrode
K Number: K241917
·
Decision Jul 31, 2024
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
94
Applicant Total
2
Review Days
30
Basic Information
- Device Name
- EARP Nerve Cuff Electrode
- K Number
- K241917
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Retropsoas Technologies, LLC
- Date Received
- July 1, 2024
- Decision Date
- July 31, 2024
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Retropsoas Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242457 | EARP Interbody System | Oct 7, 2024 | Substantially Equivalent |