Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K190081 · 2019-08-21

ApplicantSTERIS Corporation
Decision Date2019-08-21
Product CodeNVE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-08-21 under approval number K190081. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2019-08-21. It is manufactured by STERIS Corporation. The 510(k) number is K190081.

When was RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector approved by the FDA?

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector received FDA 510(k) clearance on 2019-08-21, under approval number K190081.

What company makes RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is manufactured by STERIS Corporation.

What is the FDA product code for RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

The FDA product code for RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is NVE.

Related Clinical Trials

NCT06968026 Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety RECRUITING NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT05270499 Aveir VR Real-World Evidence Post-Approval Study ACTIVE_NOT_RECRUITING NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT03873259 Intraoperative Assessment of of Burst Wave Lithotripsy (BWL) RECRUITING NCT07106788 Aveir Leadless Pacemaker Japan PMS RECRUITING

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

View all 119 devices →

Related Devices (Code: NVE)

K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-DisinfectorSTERIS Corporation K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSteris K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSteris

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑