510(k) K051326 ยท HRX Arthroscope
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jun 15, 2005 |
| Received | May 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2009 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction
Catalog Number: 7211005 Terminated |
HRX | None listed |
| Sep 21, 2009 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction
Catalog Number: 7211006 Terminated |
HRX | None listed |
| Sep 21, 2008 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field. Terminated |
HRX | None listed |
| Sep 21, 2008 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Single Suction. Catalog # 7211005. Bag is used for remote in a ster Terminated |
HRX | None listed |
| Sep 21, 2008 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Forked Suction. Catalog # 7211006. Bag is used for remote control i Terminated |
HRX | None listed |
| Sep 21, 2008 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.