RIDGEFIELD, N.J. -- Officials at Case Medical, Inc., have been granted FDA 510k pre-market clearance for their FlashTite filter-less system with MediTray products.
The systems allow healthcare workers to rapidly sterilize medical devices in a pre-vacuum flash and gravity displacement flash steam cycle.
The SteriTite sealed container system and the MediTray products are the only sterilization system that have been granted the FDA 510k for use in steam sterilization, EO, STERAD sterilization and flash. The products can be can either be wrapped or used as inserts in the sealed container system.
The system was designed following AAMI standards and AORN recommended practices; it can be used in abbreviated cycles, using fractional and half-cycle parameters.
For more information, called (888) 227-CASE, x. 225.