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AquaBeam Handpiece

FDA UDI

Class II (US FDA UDI)

by PROCEPT BioRobotics Corporation

Identity

Trade Name
AquaBeam Handpiece FDA UDI
Generic Name
Water jet knife system handpiece, single-use FDA UDI
Model / Reference
HP2000 FDA UDI

Identifiers

Catalog Number
HP2000-C FDA UDI
Primary DI / UDI-DI
00850055427037 FDA UDI
510(k) Number
K231024 FDA UDI
FDA Product Code
PZP FDA UDI
GMDN Term
Water jet knife system handpiece, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Water jet knife system handpiece, single-use

AquaBeam Handpiece by PROCEPT BioRobotics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Water jet knife system handpiece, single-use.

Cleared under the same submission

K231024 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PROCEPT BioRobotics Corporation

Sources (1)

  • FDA UDI 9722035e-12bd-4a87-a3bc-dcbe1e796195 36 fields · synced Jun 8, 2026