Identity
- Trade Name
- AquaBeam Handpiece EUDAMEDFDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- AquaBeam Handpiece EUDAMED
- Model / Reference
- HP2000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- HP2000 FDA UDIHP2000-D FDA UDI
- Primary DI / UDI-DI
- 00850055427006 EUDAMEDFDA UDIB614HP2000X1 FDA UDI
- Basic UDI-DI
- 0850055427HP2000MF EUDAMED
- FDA Product Code
- PZP FDA UDI
- EMDN Code
- Z120106 HYDRODISSECTORS EUDAMED
- GMDN Term
- Water jet knife system handpiece, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Water jet knife system handpiece, single-use
AquaBeam Handpiece by PROCEPT BioRobotics Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Water jet knife system handpiece, single-use.
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- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
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Cleared under the same submission
K212835 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROCEPT BioRobotics Corporation
Sources (3)
- FDA UDI 615abdc0-4382-4ca3-9d23-69786a6ac748 36 fields · synced Jul 11, 2026
- FDA UDI e2f33579-11ca-407e-be11-1c2ce411eca6 36 fields · synced May 30, 2026
- EUDAMED 42e8d54d-f8e0-4fd7-a1df-d701e0ad6d7f 61 fields · synced Jul 11, 2026