510(k) K951843 ยท HRX Arthroscope
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
| Applicant | Future Medical Systems, Inc., New York City NY, US |
| Decision | Substantially Equivalent, Jul 14, 1995 |
| Received | Apr 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Intermediary Tubing with One-Way valve
Product Code: 281142
Product Usage:
The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic she Terminated |
HRX | None listed |
| Apr 12, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing
Product Code: 281142
Fluid Tissue Management Terminated |
HBX | None listed |
| Apr 12, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box)
(International Distribution Only)
Product Code: 281102
Fluid Tissue Management Terminated |
HBX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.