Company ยท US
Procept Biorobotics
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (2 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PZP | Fluid Jet Removal System | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2026 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) Procept Biorobotics | PZP |
| Jun 23, 2026 | K253211 | AQUABEAM Robotic System Procept Biorobotics | PZP |
| Oct 10, 2025 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) Procept Biorobotics | PZP |
| Sep 30, 2024 | K241952 | AQUABEAM Robotic System (AB2000) Procept Biorobotics | PZP |
| Aug 20, 2024 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece Procept Biorobotics | PZP |
| Aug 30, 2023 | K231024 | AquaBeam Robotic System Procept Biorobotics, Corporation | PZP |
| Oct 6, 2021 | K212835 | AquaBeam Robotic System Procept Biorobotics, Corporation | PZP |
| Mar 11, 2021 | K202961 | AquaBeam Robotic System Procept Biorobotics, Corporation | PZP |
| Dec 21, 2017 | DEN170024 | AQUABEAM System Procept Biorobotics, Corporation | PZP |
Latest recalls
| 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 | K202961 |
| Mar 6, 2019 | PROCEPT BIOROBOTICS CORPORATION AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S.
Device Description The AQUABEAM Robotic System is intend Terminated |
PZP | None listed |