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510(k) Data Aggregation
K Number
K241952Device Name
AQUABEAM Robotic System (AB2000)
Manufacturer
Date Cleared
2024-09-30
(89 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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 wateriet 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 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
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K Number
K240200Device Name
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Manufacturer
Date Cleared
2024-08-20
(208 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HYDROS™ 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 Description
The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
1. HYDROS Robotic System: consists of the HYDROS Tower, Touchscreen Interfaces Monitor, HYDROS Software, HYDROS Operating System, Embedded Software, Motorpack, Handpiece Arm, TRUS Probe Arm, and Foot Pedal. It is provided non-sterile and reprocessed per instructions. It does not contact patients during the procedure.
2. HYDROS TRUS Probe: a biplane transrectal ultrasound probe used with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging for the AQUABLATION procedure. It is re-usable, provided non-sterile, and reprocessed prior to each use.
3. HYDROS Handpiece: a single-use sterile surgical device introduced through the urethra to visualize, resect and remove prostatic tissue. It is integrated with a digital CMOS Scope and terminally sterilized by EtO.
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K Number
K231024Device Name
AquaBeam Robotic System
Manufacturer
Date Cleared
2023-08-30
(141 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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 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.
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K Number
K212835Device Name
AquaBeam Robotic System
Manufacturer
Date Cleared
2021-10-06
(29 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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 highpressure 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. Precondition 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
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K Number
K202961Device Name
AquaBeam Robotic System
Manufacturer
Date Cleared
2021-03-11
(162 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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 wateriet 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 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
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K Number
DEN170024Device Name
AQUABEAM System
Manufacturer
Date Cleared
2017-12-21
(248 days)
Product Code
Regulation Number
876.4350Why did this record match?
Product Code :
PZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AOUABEAM 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 Description
The AQUABEAM System is a personalized image-guided prostate tissue removal system that uses a high-velocity water jet to resect and remove a predetermined volume of tissue. The AQUABEAM System is comprised of nine main components along with accessories: AQUABEAM Conformal Planning Unit, AQUABEAM Console, AQUABEAM Motorpack, AQUABEAM Roll Stand, AQUABEAM Foot Pedal, AQUABEAM Handpiece Articulating Arm, AQUABEAM TRUS Articulating Arm, AQUABEAM Handpiece, and AQUABEAM Scope.
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