Data / Medical devices / United States / PROCEPT BioRobotics Corporation
PROCEPT BioRobotics Corporation: FDA-registered device maker in San Jose, CA, United States, 9 510(k) clearances
PROCEPT BioRobotics Corporation is registered with the FDA (registration 3027788423) in San Jose, CA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 9, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027788423
- Address
- 150 Baytech Drive, San Jose, CA, United States, 95134
- Owner or operator
- PROCEPT BioRobotics Corporation (10055490)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 31, 2017
- Registered through
- 2026
- Brand names listed
- AQUABEAM Robotic System, AQUABEAM® Robotic System, Aquablation Essential Drape Pack, DR2500, HYDROS Handpiece, HYDROS Robotic System, HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000), HYDROS TRUS Probe, Lithotomy Drape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Urological, Disposable | EYY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Fluid Jet Removal System | PZP | 2 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2026 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | PZP | Substantially Equivalent | Procept Biorobotics | accessdata.fda.gov |
| June 23, 2026 | K253211 | AQUABEAM Robotic System | PZP | Substantially Equivalent | Procept Biorobotics | accessdata.fda.gov |
| October 10, 2025 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | PZP | Substantially Equivalent | Procept Biorobotics | accessdata.fda.gov |
| September 30, 2024 | K241952 | AQUABEAM Robotic System (AB2000) | PZP | Substantially Equivalent | Procept Biorobotics | accessdata.fda.gov |
| August 20, 2024 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | PZP | Substantially Equivalent | Procept Biorobotics | accessdata.fda.gov |
| August 30, 2023 | K231024 | AquaBeam Robotic System | PZP | Substantially Equivalent | Procept Biorobotics, Corporation | accessdata.fda.gov |
| October 6, 2021 | K212835 | AquaBeam Robotic System | PZP | Substantially Equivalent | Procept Biorobotics, Corporation | accessdata.fda.gov |
| March 11, 2021 | K202961 | AquaBeam Robotic System | PZP | Substantially Equivalent | Procept Biorobotics, Corporation | accessdata.fda.gov |
| December 21, 2017 | DEN170024 | AQUABEAM System | PZP | Unknown | Procept Biorobotics, Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 9, 2021 | 88337 | Class II | Ongoing | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. | 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 t | accessdata.fda.gov |
| March 6, 2019 | 82462 | Class II | Terminated | 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 intended for use in patients | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Fluid Jet Removal System
- All makers of Drape, Urological, Disposable
Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.