FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Surgeon Controlled Arm
K Number: K223673
·
Decision Aug 4, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
8
Review Days
240
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Basic Information
- Device Name
- Surgeon Controlled Arm
- K Number
- K223673
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4815
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Levita Magnetics International Corp
- Date Received
- December 7, 2022
- Decision Date
- August 4, 2023
- Product Code
- PNL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PNL | Magnetic Surgical System | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNL), ordered by most recent decision date.
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Other Clearances by Levita Magnetics International Corp
| K Number | Device Name | ||
|---|---|---|---|
| K252435 | Magnetic Surgical System | Sep 26, 2025 | Substantially Equivalent |
| K250746 | Magnetic Surgical System | Jun 7, 2025 | Substantially Equivalent |
| K191762 | Magnetic Surgical System | Apr 1, 2020 | Substantially Equivalent |
| K190006 | Magnetic Surgical System | Apr 29, 2019 | Substantially Equivalent |
| K180894 | Magnetic Surgical System | Sep 19, 2018 | Substantially Equivalent |
| K171429 | Magnetic Surgical System | Jun 6, 2017 | Substantially Equivalent |
| DEN150007 | Magnetic Surgical System | Jun 13, 2016 | Unknown |