meddevicedb.com FDA Device Reference

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)

K203061 Class II Special
Decision Date
2020-11-06
Sponsor / Applicant
STERIS Corporation

Technical Specification

510(k) Submission ID K203061
Product Code FLE
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6880
Decision Date 2020-11-06
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) received FDA 510(k) clearance under submission number K203061, sponsored by STERIS Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-11-06.

Classification & Regulation

This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.