Organization name

PROCEPT BioRobotics Corporation

SRN

US-MF-000015560

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW007

  EUDAMED did not publish a description for this code.
• CW999

  • Do not use the AquaBeam Robotic System in patients who do not meet the indication for the System’s intended use. • Do not use the System in patients with: ○ Active urinary tract or systemic infection ○ Inability to safely stop anticoagulants or antiplatelet agents perioperatively
• CW018

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 10 countries total.

Trade name

AquaBeam Robotic System

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00850055427020

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0850055427AB2000DS

Reference / catalog number

AB2000

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The AquaBeam® Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). 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 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 components: • AquaBeam Console (Console) • AquaBeam Motorpack (Motorpack) • AquaBeam Foot Pedal (Foot Pedal) • AquaBeam Conformal Planning Unit (CPU) • AquaBeam Roll Stand (Roll Stand) • AquaBeam Handpiece Articulating Arm (Handpiece Articulating Arm) • AquaBeam TRUS Articulating Arm (TRUS Articulating Arm) • AquaBeam Handpiece (Handpiece) • AquaBeam Scope (Scope)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z120106HYDRODISSECTORS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.