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AquaBeam System

FDA UDI

Class II (US FDA UDI)

by PROCEPT BioRobotics Corporation

Identity

Trade Name
AquaBeam System FDA UDI
Generic Name
Water jet knife system FDA UDI
Model / Reference
210101 FDA UDI

Identifiers

Catalog Number
210101 FDA UDI
Primary DI / UDI-DI
B6142101011 FDA UDI
510(k) Number
DEN170024 FDA UDI
FDA Product Code
PZP FDA UDI
GMDN Term
Water jet knife system 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Water jet knife system

AquaBeam System 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.

Cleared under the same submission

DEN170024 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 4ef2ad82-a7a5-4abd-b43c-771da047ea82 34 fields · synced Jun 1, 2026