510(k) K202961 ยท PZP Fluid Jet Removal System
AquaBeam Robotic System
| Applicant | Procept Biorobotics, Corporation, Redwood City CA, US |
| Decision | Substantially Equivalent, Mar 11, 2021 |
| Received | Sep 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202961
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2021 | PROCEPT BIOROBOTICS CORPORATION AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. Open, Classified |
PZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.