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AquaBeam Robotic System

FDA UDI

Class II (US FDA UDI)

by PROCEPT BioRobotics Corporation

Identity

Trade Name
AquaBeam Robotic System FDA UDI
Generic Name
Water jet knife system FDA UDI
Model / Reference
AB2000C FDA UDI

Identifiers

Catalog Number
AB2000 FDA UDI
Primary DI / UDI-DI
B614AB2000C1 FDA UDI
510(k) Number
K202961 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
MRI Safety
MR Unsafe FDA UDI

Category: Water jet knife system

AquaBeam Robotic 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.

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 14797544-9d27-4556-bfc5-3958451cf292 36 fields · synced May 30, 2026