Identity
- Trade Name
- HYDROS Handpiece EUDAMEDFDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- HYDROS Handpiece EUDAMED
- Model / Reference
- HH1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850055427051 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850055427HH1000JG EUDAMED
- 510(k) Number
- K240200 FDA UDI
- 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
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Water jet knife system handpiece, single-use
HYDROS Handpiece by PROCEPT BioRobotics Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Water jet knife system handpiece, single-use.
- Versajet — Smith & Nephew Medical, Ltd. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- Versajet — Smith & Nephew Medical, Ltd. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
Cleared under the same submission
K240200 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 |
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Manufacturer
- Manufacturer
- PROCEPT BioRobotics Corporation
Sources (2)
- FDA UDI 07ec7d2d-9864-4426-a937-4da64b589be9 35 fields · synced Jul 21, 2026
- EUDAMED 94f5c945-4cab-4bc9-91c5-8a2c5ee34a88 61 fields · synced Jul 21, 2026