K253211 · Procept Biorobotics · PZP · Jun 23, 2026 · General, Plastic Surgery
Device Facts
Record ID
K253211
Device Name
AQUABEAM Robotic System
Applicant
Procept Biorobotics
Product Code
PZP · General, Plastic Surgery
Decision Date
Jun 23, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.4350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The AQUABEAM Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Device Story
AquaBeam Robotic System performs minimally invasive prostate tissue resection; utilizes high-velocity sterile saline waterjet as cutting medium. System components include console, motorpack, foot pedal, conformal planning unit, roll stand, articulating arms, handpiece, and scope. Surgeon inserts handpiece/scope transurethrally into prostatic urethra; high-pressure pump system generates waterjet; nozzle motion controlled by motor system. User sets pre-condition parameters and adjusts flow rates via conformal planning unit. Device images treatment area to monitor progress. System facilitates precise tissue removal; benefits patients by treating BPH-related LUTS.
Clinical Evidence
No new clinical data provided. Reliance on pre-existing non-clinical performance data including biocompatibility, sterilization, software/firmware verification, electrical safety, EMC, usability, and system design verification and validation.
Technological Characteristics
Fluid jet system for prostate tissue removal (21 CFR 876.4350). Components: console, motorpack, foot pedal, conformal planning unit, roll stand, articulating arms, handpiece, scope. Principle: high-velocity sterile saline waterjet cutting. Energy: high-pressure pump system. Connectivity: integrated system console and planning unit. Sterilization: not specified. Software: firmware for motor control and planning unit parameters.
Indications for Use
Indicated for resection and removal of prostate tissue in males with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Regulatory Classification
Identification
A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.
Special Controls
In combination with the general controls of the FD&C Act, the fluid jet system for prostate tissue removal is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and non-target tissues.
(5) Software verification, validation, and hazard analysis must be performed.
(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 23, 2026
Procept BioRobotics
Ankur Kaushal
VP, Global Regulatory Affairs
150 Baytech Drive
San Jose, California 95134
Re: K253211
Trade/Device Name: AQUABEAM Robotic System
Regulation Number: 21 CFR 876.4350
Regulation Name: Fluid Jet System for Prostate Tissue Removal
Regulatory Class: II
Product Code: PZP
Dated: September 26, 2025
Received: September 29, 2025
Dear Ankur Kaushal:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253211 - Ankur Kaushal
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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K253211 - Ankur Kaushal
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253211
Device Name
AquaBeam Robotic System
Indications for Use (Describe)
The AquaBeam Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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PROCEPT
BIOROBOTICS®
K253211
Page 1 of 2
# 510(k) SUMMARY
Date Prepared: June 23, 2026
| **Owner/Sponsor** | PROCEPT BioRobotics Corporation 150 Baytech Dr., San Jose, 95134 USA |
| --- | --- |
| **Submitter** | Contact Name: Ankur Kaushal Title: VP, Global Regulatory Affairs Address: 150 Baytech Dr., San Jose, CA 95134, USA Telephone: (650) 232-7200 ext. 10378 Email: a.kaushal@procept-biorobotics.com |
| **Trade Name** | AquaBeam Robotic System |
| **Classification** | Class II |
| **Classification Name** | PZP - Fluid jet system for prostate tissue removal |
| **Common Name** | Fluid jet system for prostate tissue removal |
| **Common Name and Product Code** | PZP A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia (BPH). The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress. |
| **Regulation Number** | PZP - 21 CFR 876. 4350 |
# **Predicate Device**
Trade Name - AQUABEAM ROBOTIC System
510(k) Number – K241952 cleared on September 30, 2024.
Product Code – PZP
Regulation Number: 876. 4350
Device Classification - Class II
# **Device Description**
The AquaBeam Robotic System is designed for resecting of prostate tissue during minimally invasive surgical procedures. The AquaBeam Handpiece and AquaBeam Scope are inserted via transurethral approach and advanced into the prostatic urethra.
The AquaBeam Robotic System is designed to utilize a high-velocity sterile saline waterjet as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly
PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · info@PROCEPT-BioRobotics.com
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PROCEPT
BIOROBOTICS®
K253211
Page 2 of 2
motion is driven by a motor system, controlled by the user. The pressure is generated by a high-pressure pump system controlled by the AquaBeam Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on the AquaBeam Conformal Planning Unit. Pre-condition parameters are set on the AquaBeam Conformal Planning Unit before operation.
The AquaBeam Robotic System, consists of the following nine components:
- AquaBeam Console
- AquaBeam Motorpack
- AquaBeam Foot pedal
- AquaBeam Conformal Planning Unit
- AquaBeam Roll Stand
- AquaBeam Handpiece Articulating Arm
- AquaBeam TRUS Articulating Arm
- AquaBeam Handpiece
- AquaBeam Scope
### Intended Use/Indications for Use
The AQUABEAM Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
### Technological Comparison as compared to the Predicate Device
The subject device remains technologically equivalent to the predicate device.
### Performance Data
The device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device. The following pre-existing nonclinical data continues to be relied upon to support the safety and effectiveness of the subject device:
- Biocompatibility
- Sterilization
- Software and Firmware verification
- Electrical Safety and EMC Compatibility
- Usability
- System Design Verification and Validation
- Reliability Testing
### Conclusion:
The overall performance, together with the non-clinical performance testing performed on the device, supports that the AquaBeam Robotic System is as safe & effective, and performs as well as the legally marketed predicate device.
The materials provided in this traditional 510(k) premarket notification demonstrate compliance to the special controls prescribed in 21 CFR 876.4350.
PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · info@PROCEPT-BioRobotics.com
