FDA.reportPublic FDA data

AquaBeam Handpiece

Primary DI
00850055427006
Brand
AquaBeam Handpiece
Company
PROCEPT BioRobotics Corporation
Model
HP2000
Catalog number
HP2000-D
Published
2023-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
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
K212835000
K231024000
K241952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212835000AquaBeam Robotic SystemProcept Biorobotics, Corporation2021-10-06PZP
K231024000AquaBeam Robotic SystemProcept Biorobotics, Corporation2023-08-30PZP
K241952000AQUABEAM Robotic System (AB2000)Procept Biorobotics2024-09-30PZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055427006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055427006008500554270068500554270060850055427006

GMDN Terms#

Term, Definition table
TermDefinition
Water jet knife system handpiece, single-useA sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
016646472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
B6142101011AquaBeam System2101012101012018-01-11
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
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
B6142101011AquaBeam SystemPROCEPT BioRobotics CorporationPZP2018-01-11
B6142105011AquaBeam ScopePROCEPT BioRobotics CorporationPZP2018-01-11
B6143103011AquaBeam HandpiecePROCEPT BioRobotics CorporationPZP2018-01-11