Data / Medical devices / Netherlands / Procept Biorobotics c/o HealthLink Europe B.V.
Procept Biorobotics c/o HealthLink Europe B.V.: FDA-registered device maker in Waalwijk Noord-Brabant, Netherlands, 3 510(k) clearances
Procept Biorobotics c/o HealthLink Europe B.V. is registered with the FDA (registration 3043534483) in Waalwijk Noord-Brabant, Netherlands. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3043534483
- Address
- Mechie Trommelenweg 8, Waalwijk Noord-Brabant, Netherlands, 5145 ND
- Owner or operator
- PROCEPT BioRobotics Corporation (10055490)
- Roles
- Exporter to the US
- First device listed
- August 31, 2017
- Registered through
- 2026
- Brand names listed
- Apogee 2300 with transducers ECBP-1, Aquablation Essential Drape Pack, DR2500, HYDROS Handpiece, HYDROS Robotic System, HYDROS TRUS Probe, Lithotomy Drape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Urological, Disposable | EYY | 2 | Exporter to the US | accessdata.fda.gov |
| Fluid Jet Removal System | PZP | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 10, 2025 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | 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 |
| December 7, 2017 | K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Urological, Disposable
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Fluid Jet Removal System
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated October 10, 2025. 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.