Data / Medical devices / United States / Hydrocision, Inc.
Hydrocision, Inc.: FDA-registered device maker in Billerica, MA, United States, 4 510(k) clearances
Hydrocision, Inc. is registered with the FDA (registration 1226424) in Billerica, MA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 16, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226424
- FEI number
- 3003018854
- Address
- 267 Boston Road Suite 28, Billerica, MA, United States, 01862
- Owner or operator
- HYDROCISION, INC. (9041017)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 10, 2000
- Registered through
- 2026
- Brand names listed
- HydroCision ArthroJet System with Cautory Turbo Burr and Currette, (51300, 51310), HydroCision ArthroJet System with Cautory and Burr, HydroCision Console, HydroCision SpineJet System, HydroCision TenJet Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2020 | K200729 | HydroCision SpineJet System | HRX | Substantially Equivalent | Hydrocision, Inc. | accessdata.fda.gov |
| June 5, 2019 | K190804 | HydroCision TenJet Device | HRX | Substantially Equivalent | Hydrocision, Inc. | accessdata.fda.gov |
| September 16, 2003 | K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | HRX | Substantially Equivalent | Hydrocision, Inc. | accessdata.fda.gov |
| November 24, 2000 | K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | HRX | Substantially Equivalent | Hydrocision, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 7, 2006 | 36240 | Not yet classified | Terminated | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Arthroscope
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Updated April 16, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.