Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043534483

FEI Number

3043534483

Entity Name

Procept Biorobotics c/o HealthLink Europe B.V.

City/State/Country

Waalwijk Noord-Brabant, NL

Establishment Address

Mechie Trommelenweg 8, Waalwijk Noord-Brabant 5145 ND, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

PROCEPT BioRobotics Corporation (Owner Number: 10055490)

Owner / Operator Contact Address

150 Baytech Drive, San Jose, CA 95134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Apogee 2300 with transducers ECBP-1 Lithotomy Drape Aquablation Essential Drape Pack, DR2500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-02-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-02-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-02-05
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2017-08-31

Official Correspondent

Ankur Kaushal

US Agent Details

Ankur Kaushal Business: PROCEPT BIOROBOTICS CORPORATION Email: a.kaushal@procept-biorobotics.com Phone: (650) 2327200

Related Public Records

Same Entity

PROCEPT BioRobotics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027788423	PROCEPT BioRobotics Corporation	San Jose, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number	Establishment Name	Location
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3025786376	ACO HEALTHCARE CO., LTD.	Taoyuan City, TW
3004752776	Compumedics Germany GmbH	Singen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043534483. Last updated year: 2026. Please use registration number 3043534483 when referencing this establishment in official correspondence.