Identity
- Trade Name
- HydroCision Console FDA UDI
- Generic Name
- Water jet knife system generator FDA UDI
- Device Name
- HydroCision Console FDA UDI
- Model / Reference
- 52700 FDA UDI
- Description
- HydroCision Console FDA UDI
Identifiers
- Catalog Number
- 52700 FDA UDI
- Primary DI / UDI-DI
- 00853235007043 FDA UDI
- 510(k) Number
- K002764 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Water jet knife system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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 generator
HydroCision Console by Hydrocision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HydroCision Console — HYDROCISION, INC. · Class II
Cleared under the same submission
K002764 also covers:
- Allograft — HYDROCISION, INC.
- Allograft-ALT — HYDROCISION, INC.
- Cannula — HYDROCISION, INC.
- HydroCision Console — HYDROCISION, INC.
- Knob — HYDROCISION, INC.
- QuickKart Procedure Cart — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Hydrocision, Inc.
Sources (1)
- FDA UDI cb1e2f16-ccbf-45a2-98eb-79c3384fe0cc 35 fields · synced May 30, 2026