FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AquaBeam Robotic System
K Number: K231024
·
Decision Aug 30, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
6
Applicant Total
4
Review Days
141
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Basic Information
- Device Name
- AquaBeam Robotic System
- K Number
- K231024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procept Biorobotics, Corporation
- Date Received
- April 11, 2023
- Decision Date
- August 30, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PZP), ordered by most recent decision date.
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
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