Hydrocision, Inc.
Billerica, MA, US
HYDROCISION, INC. appears in FDA device records in Billerica, MA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Hydrocision, Inc. between 1998 and 2025. The busiest year on record is 2000, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241990 | SpineSite Endoscope System | HRX | Substantially Equivalent | |
| K200729 | HydroCision SpineJet System | HRX | Substantially Equivalent | |
| K190804 | HydroCision TenJet Device | HRX | Substantially Equivalent | |
| K041233 | ARTHROJET XT | HRX | Substantially Equivalent | |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | HRX | Substantially Equivalent | |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | FQH | Substantially Equivalent | |
| K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR | HRX | Substantially Equivalent | |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | FQH | Substantially Equivalent | |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | HRX | Substantially Equivalent | |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | FQH | Substantially Equivalent | |
| K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY | HRX | Substantially Equivalent | |
| K982266 | HYDROCISION ARTHROJET SYSTEM | HRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1226424 | 3003018854 | HYDROCISION, INC. | 267 Boston Road, BILLERICA, MA 01862 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0124-2007 | Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663 | Distal tip may become detached from the device | Terminated | ||
| Z-0123-2007 | HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58662 | Distal tip may become detached from the device | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain