AccessGUDID - DEVICE: AquaBeam Handpiece (B614HP2000X1)

GUDID

Device Identifier (DI) Information

Brand Name: AquaBeam Handpiece
Version or Model: HP2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HP2000
Company Name: PROCEPT BioRobotics Corporation

Primary DI Number: B614HP2000X1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016646472 *Terms of Use
Previous DI: B614HP20001

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47559	Water jet knife system handpiece, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZP	Fluid jet removal system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212835	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 615abdc0-4382-4ca3-9d23-69786a6ac748
Public Version Date: January 19, 2026
Public Version Number: 2
DI Record Publish Date: May 31, 2022