Hydrocision, Inc.
Medical device manufacturer in North Billerica, MA.
12510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241990 | SpineSite Endoscope SystemHRX · Traditional | 07/30/2025SE |
| K200729 | HydroCision SpineJet SystemHRX · Special | 04/16/2020SE |
| K190804 | HydroCision TenJet DeviceHRX · Traditional | 06/05/2019SE |
| K041233 | Arthrojet XTHRX · Special | 07/28/2004SE |
| K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310HRX · Special | 09/16/2003SE |
| K021813 | Hydrocision General Surgery Fluidjet SystemFQH · Traditional | 05/09/2003SE |
| K020688 | Hydrocision Arthojet System with Cautery and TurboburrHRX · Special | 04/03/2002SE |
| K011612 | Modification to Hydrocision Debridement SystemFQH · Special | 06/22/2001SE |
| K002764 | Hydrocision Arthrojet System with Cautery and BurrHRX · Traditional | 11/24/2000SE |
| K991383 | Hydrocision Debdridement SystemFQH · Traditional | 03/31/2000SE |
| K993009 | Hydrocision Arthrojet System with CauteryHRX · Traditional | 10/25/1999SE |
| K982266 | Hydrocision Arthrojet SystemHRX · Traditional | 09/25/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0124-2007 | Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of…Distal tip may become detached from the device | 09/07/2006Terminated |
| Z-0123-2007 | HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of…Distal tip may become detached from the device | 09/07/2006Terminated |