FDA.reportPublic FDA data

AquaBeam System

Primary DI
B6142101011
Brand
AquaBeam System
Company
PROCEPT BioRobotics Corporation
Model
210101
Catalog number
210101
Published
2018-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZPFluid jet removal system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZPFluid Jet Removal SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170024000AQUABEAM SystemProcept Biorobotics, Corporation2017-12-21PZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6142101011PrimaryHIBCC0
B614AB20001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Water jet knife systemAn assembly of devices designed to surgically cut/dissect soft body tissues using a stream of high pressure water, leaving hard/elastic structures (e.g., bone, ligaments) intact. It includes a mains electricity (AC-powered) generator to create the hydraulic pressure, tubing, and a handpiece to direct and apply the cutting stream of water; this is typically sterile saline. It may also assist in the irrigation of the surgical site to help improve site visibility. The system is commonly used to remove burned/damaged skin, tumours, and varicose veins; it may be used endoscopically.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unless otherwise stated, the following conditions apply for operation use as well as transport and storage.
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)232-7222customerservice@procept-biorob
+1(650)232-7222customerservice@procept-biorobotics.com

Regulatory Flags#

DUNS number
016646472
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055427051HYDROS HandpieceHH10002024-09-06
00850055427068HYDROS Robotic SystemHY10002024-09-06
00850055427075HYDROS TRUS ProbeHU10002024-09-06
00850055427037AquaBeam HandpieceHP2000HP2000-C2023-12-15
00850055427006AquaBeam HandpieceHP2000HP2000-D2023-08-25
00850055427013AquaBeam ScopeSC2000SC2000-D2023-08-25
00850055427020AquaBeam Robotic SystemAB2000AB2000-D, AB2000-E2023-08-25
00850055427129AquaBeam HandpieceHP2000HP2000-E2026-04-28
B614AB20001AquaBeam Robotic SystemAB2000AB20002019-03-28
B614HP2000X1AquaBeam HandpieceHP2000HP20002022-05-31
B614SC20001AquaBeam ScopeSC2000SC2000-A2019-03-28
00850055427099Essential Drape 1PKDR2500DR25002025-03-13
00860009122932Lithotomy DrapeFG351101FG3511012023-04-05
00850055427044Lithotomy DrapeFG3511013511012023-12-15
B614HP20001AquaBeam HandpieceHP2000HP20002019-03-28
B614AB2000C1AquaBeam Robotic SystemAB2000CAB20002021-04-06
B6142105011AquaBeam Scope2105012105012018-01-11
B6143103011AquaBeam Handpiece3103012018-01-11
B6143511011Lithotomy Drape3511013511012017-12-06
10850055427096Essential Drape 1PKDR2500DR25002025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850055427129AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2026-04-28
00850055427051HYDROS HandpiecePROCEPT BioRobotics CorporationPZP2024-09-06
00850055427068HYDROS Robotic SystemPROCEPT BioRobotics CorporationPZP2024-09-06
00850055427037AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2023-12-15
00850055427006AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2023-08-25
00850055427013AquaBeam ScopePROCEPT BioRobotics CorporationPZP2023-08-25
00850055427020AquaBeam Robotic SystemPROCEPT BioRobotics CorporationPZP2023-08-25
B614HP2000X1AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2022-05-31
B614AB2000C1AquaBeam Robotic SystemPROCEPT BioRobotics CorporationPZP2021-04-06
B614AB20001AquaBeam Robotic SystemPROCEPT BioRobotics CorporationPZP2019-03-28
B614SC20001AquaBeam ScopePROCEPT BioRobotics CorporationPZP2019-03-28
B614HP20001AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2019-03-28
B614SC20000AquaBeam ScopePROCEPT BIOROBOTICS CORPORATIONPZP2019-03-28
B614AB2000AQUABEAM Robotic SystemPROCEPT BIOROBOTICS CORPORATIONPZP2019-01-29
B6142105011AquaBeam ScopePROCEPT BioRobotics CorporationPZP2018-01-11
B6143103011AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2018-01-11