meddevicedb.com FDA Device Reference

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

K200577 Class II Special
Decision Date
2020-04-03
Sponsor / Applicant
STERIS Corporation

Technical Specification

510(k) Submission ID K200577
Product Code NVE
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1500
Decision Date 2020-04-03
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector received FDA 510(k) clearance under submission number K200577, sponsored by STERIS Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-04-03.

Classification & Regulation

This clearance is catalogued under FDA product code NVE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.