FDA Product Code FLE: Sterilizer, Steam

Steam sterilization is the most widely used method for processing reusable surgical instruments. FDA product code FLE covers steam sterilizers — autoclaves — used in healthcare settings.

These pressure vessels use saturated steam at elevated temperature and pressure to achieve sterilization of metal instruments, textiles, and compatible materials. Modern autoclaves include gravity displacement and vacuum-assisted cycles for different load types.

FLE devices are Class II medical devices, regulated under 21 CFR 880.6880 and reviewed by the FDA General Hospital panel.

Leading manufacturers include STERIS Corporation, Maquet GmbH (A Getinge Group Company) and Enbio Group AG.