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Sign in to claim this brandPROCEPT BioRobotics Corporation
United States·US-MF-000015560
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 150 Baytech Dr., San Jose, United States
- Website
- www.procept-biorobotics.com/
- —
- —
- [email protected]
- Phone
- +1 6502327200
- PRRC Contact
- Bijesh Chandran
- EUDAMED SRN
- US-MF-000015560
- FDA FEI Number
- 3027788423
- DUNS Number
- —
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AquaBeam System | 210101 | FDA UDI | Class II | Active |
| Essential Drape 1PK | DR2500 | FDA UDI | Class II | Active |
| AquaBeam Handpiece | HP2000 | FDA UDI | Class II | Active |
| AquaBeam Scope | SC2000 | FDA UDI | Class II | Active |
| Lithotomy Drape | 351101 | FDA UDI | Class II | Active |
| Lithotomy Drape | FG351101 | FDA UDI | Class II | Active |
| AquaBeam Handpiece | HP2000 | FDA UDI | Class II | Active |
| AquaBeam Robotic System | AB2000C | FDA UDI | Class II | Active |
| HYDROS Handpiece | HH1000 | EUDAMEDFDA UDI | Class II | Active |
| HYDROS TRUS Probe | HU1000 | FDA UDI | Class II | Active |
| HYDROS Robotic System | HY1000 | FDA UDI | Class II | Active |
| AquaBeam Handpiece | 310301 | EUDAMEDFDA UDI | Class II | Active |
| Lithotomy Drape | FG351101 | FDA UDI | Class II | Active |
| AquaBeam Robotic System | AB2000 | FDA UDI | Class II | Active |
| AquaBeam Scope | 210501 | EUDAMEDFDA UDI | Class II | Active |
| AquaBeam Handpiece | HP2000 | EUDAMEDFDA UDI | Class II | Active |
| AquaBeam Robotic System | AB2000 | FDA UDI | Class II | Active |
| HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | K251082 | FDA 510(k) | Class II | Active |
| AquaBeam Robotic System | K202961 | FDA 510(k) | Class II | Active |
| AQUABEAM System | DEN170024 | FDA 510(k) | Class II | Active |
| AquaBeam Robotic System | K212835 | FDA 510(k) | Class II | Active |
| AquaBeam Robotic System | K231024 | FDA 510(k) | Class II | Active |
| HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | K240200 | FDA 510(k) | Class II | Active |
| AQUABEAM Robotic System (AB2000) | K241952 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 9, 2021 | Z-2330-2021 | — | open, classified | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate. |
| Mar 6, 2019 | Z-1110-2019 | — | terminated | Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure. |