SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900— 510(k) K251666

SYSTEM 1E and SYSTEM 1 endo are liquid chemical sterilant processing systems — product code MED covers reprocessing equipment used in hospitals and clinics to sterilize reusable medical devices (flexible endoscopes primarily) between patients. STERIS has been the US incumbent in this category for decades.

General Hospital panel, Traditional 510(k). MED is a specialized, regulated product code with a small number of active applicants. Clearances for model updates to cleared STERIS platforms are routine but involve detailed efficacy and materials-compatibility testing.

STERIS Corporation files from Mentor, OH. Ten-month review clock, on the longer end — consistent with the cycle times for sterilant processors, where FDA scrutinizes process validation closely.