FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUABEAM Robotic System (AB2000)
K Number: K241952
·
Decision Sep 30, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
6
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- AQUABEAM Robotic System (AB2000)
- K Number
- K241952
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procept Biorobotics
- Date Received
- July 3, 2024
- Decision Date
- September 30, 2024
- Product Code
- PZP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| PZP | Fluid Jet Removal System | FDA class 2 | General, Plastic Surgery |
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