510(k) K050738 ยท GEX Powered Laser Surgical Instrument
FT FIBER OPTIC DELIVERY SYSTEMS
| Applicant | Fibertech GmbH, Mesa AZ, US |
| Decision | Substantially Equivalent, Jun 2, 2005 |
| Received | Mar 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2018 | Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO-
Private label: SU-200-RT SmartScope Packaging.
The Laser peripherals bare laser fibers, ENT fibers and Terminated |
GEX | None listed |
| Oct 17, 2018 | Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-
Private label: SU-365-RT SmartScope Packaging.
The Laser peripherals bare laser fibers, ENT fibers and Endo Terminated |
GEX | None listed |
| Oct 17, 2018 | Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging.
The Laser peripherals bare laser fibers, ENT fibers and Endop Terminated |
GEX | None listed |
| Oct 17, 2018 | Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging.
The Laser peripherals bare laser fibers, ENT fibers and Endo Terminated |
GEX | None listed |
| Oct 17, 2018 | Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging.
The Laser peripherals bare laser fibers, ENT fibers an Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.