The following data is part of a premarket notification filed by Procept Biorobotics Corporation with the FDA for Aquabeam Robotic System.
| Device ID | K212835 |
| 510k Number | K212835 |
| Device Name: | AquaBeam Robotic System |
| Classification | Fluid Jet Removal System |
| Applicant | PROCEPT BioRobotics Corporation 900 Island Drive, Suite 101 Redwood City, CA 94065 |
| Contact | Sara Muddell |
| Correspondent | Sara Muddell PROCEPT BioRobotics Corporation 900 Island Drive, Suite 101 Redwood City, CA 94065 |
| Product Code | PZP |
| CFR Regulation Number | 876.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B614HP20001 | K212835 | 000 |
| 00850055427013 | K212835 | 000 |
| 00850055427006 | K212835 | 000 |