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Sign in to claim this brandHYDROCISION, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 267 Boston Road, BILLERICA, MA, 01862
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003018854
- DUNS Number
- 834612764
Catalogue (46)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TenJet® | 76000 | FDA UDI | Class II | Active |
| SpineJet® | 56986 | FDA UDI | Class II | Active |
| SpineJet® | 55500 | FDA UDI | Class II | Active |
| SpineJet® | 56987 | FDA UDI | Class II | Active |
| SpineJet® | 59961 | FDA UDI | Class II | Active |
| SpineJet® | 58662 | FDA UDI | Class II | Active |
| SpineJet® | 57162 | FDA UDI | Class II | Active |
| SpineJet® | 52005 | FDA UDI | Class II | Active |
| TenJet® | 76700 | FDA UDI | Class II | Active |
| TenJet® | 76400 | FDA UDI | Class II | Active |
| SpineJet® | 56000 | FDA UDI | Class II | Active |
| SpineJet® | 59662 | FDA UDI | Class II | Active |
| SpineJet® | 56110 | FDA UDI | Class II | Active |
| SpineJet® | 51739 | FDA UDI | Class II | Active |
| QuickKart Procedure Cart | 50300 | FDA UDI | Class II | Active |
| Allograft | 53150 | FDA UDI | Class II | Active |
| Cannula | 57165 | FDA UDI | Class II | Active |
| SpineJet® | 58663 | FDA UDI | Class II | Active |
| SpineJet® | 57662 | FDA UDI | Class II | Active |
| HydroCision Console | 52700 | FDA UDI | Class II | Active |
| SpineJet® | 58163 | FDA UDI | Class II | Active |
| Knob | 51705 | FDA UDI | Class II | Active |
| Allograft-ALT | 53150 ALT | FDA UDI | Class II | Active |
| SpineJet® | 57667 | FDA UDI | Class II | Active |
| SpineJet® | 52320 | FDA UDI | Class II | Active |
| Trephine | 51711 | FDA UDI | Class II | Active |
| SpineJet® | 57167 | FDA UDI | Class II | Active |
| SpineJet® | 59971 | FDA UDI | Class II | Active |
| SpineJet® | 56971 | FDA UDI | N/A | Active |
| SpineJet® | 58162 | FDA UDI | Class II | Active |
| HydroCision Console | 82700 | FDA UDI | Class II | Active |
| SpineJet® | 51786 | FDA UDI | Class II | Active |
| SpineJet® | 51740 | FDA UDI | Class II | Active |
| SpineJet® PerResector-China Version | 56000 | FDA UDI | Class II | Active |
| Hydrocision Arthrojet System With Cautery And Burr | K002764 | FDA 510(k) | Class II | Active |
| Modification To Hydrocision Debridement System | K011612 | FDA 510(k) | Class II | Active |
| Hydrocision Debdridement System | K991383 | FDA 510(k) | Class II | Active |
| Hydrocision Arthojet System With Cautery And Turboburr | K020688 | FDA 510(k) | Class II | Active |
| Hydrocision General Surgery Fluidjet System | K021813 | FDA 510(k) | Class II | Active |
| Hydrocision Arthrojet System With Cautery, Turboburr And Curette, Models 51300, 51310 | K032529 | FDA 510(k) | Class II | Active |
| Hydrocision Arthrojet System | K982266 | FDA 510(k) | Class II | Active |
| Arthrojet Xt | K041233 | FDA 510(k) | Class II | Active |
| HydroCision TenJet Device | K190804 | FDA 510(k) | Class II | Active |
| Hydrocision Arthrojet System With Cautery | K993009 | FDA 510(k) | Class II | Active |
| HydroCision SpineJet System | K200729 | FDA 510(k) | Class II | Active |
| SpineSite Endoscope System | K241990 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 7, 2006 | Z-0123-2007 | — | terminated | Distal tip may become detached from the device |
| Sep 7, 2006 | Z-0124-2007 | — | terminated | Distal tip may become detached from the device |