Company ยท US
Hydrocision, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2025 | K241990 | SpineSite Endoscope System Hydrocision, Inc. | HRX |
| Apr 16, 2020 | K200729 | HydroCision SpineJet System Hydrocision, Inc. | HRX |
| Jun 5, 2019 | K190804 | HydroCision TenJet Device Hydrocision, Inc. | HRX |
| Jul 28, 2004 | K041233 | ARTHROJET XT Hydrocision, Inc. | HRX |
| Sep 16, 2003 | K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 Hydrocision, Inc. | HRX |
| May 9, 2003 | K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM Hydrocision, Inc. | FQH |
| Apr 3, 2002 | K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR Hydrocision, Inc. | HRX |
| Jun 22, 2001 | K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM Hydrocision, Inc. | FQH |
| Nov 24, 2000 | K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR Hydrocision, Inc. | HRX |
| Mar 31, 2000 | K991383 | HYDROCISION DEBDRIDEMENT SYSTEM Hydrocision, Inc. | FQH |
| Oct 25, 1999 | K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY Hydrocision, Inc. | HRX |
| Sep 25, 1998 | K982266 | HYDROCISION ARTHROJET SYSTEM Hydrocision, Inc. | HRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2006 | Hydrocision, Inc. Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone.
Catalog Number 58663 Terminated |
HRX | K032529 |
| Nov 2, 2006 | Hydrocision, Inc. HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone.
Catalog Number 58662 Terminated |
HRX | K032529 |