510(k) K041824 ยท HRX Arthroscope
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
| Applicant | Future Medical Systems, SA, St. Jeannet, FR |
| Decision | Substantially Equivalent, Jan 7, 2005 |
| Received | Jul 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041824
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2016 | DePuy Mitek, Inc., a Johnson & Johnson Co. FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305
Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. Terminated |
HRX | None listed |
| Jan 15, 2016 | DePuy Mitek, Inc., a Johnson & Johnson Co. FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315
Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.