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510(k) K230560

Device
enspire 300 Series Automated Endoscope Reprocessor System
Applicant
STERIS Corporation
510(k) number
K230560
Product code
NZA
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-02-28
Regulation
876.1500
Classification name
Accessories, Germicide, Cleaning, For Endoscopes
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gregory Land
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NZA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation2023-10-03
K220361Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation2022-03-10
K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris2021-01-28
K200989Reliance Endoscope Processing SystemSTERIS Corporation2020-05-14
K123768RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2013-07-26
K110453RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2011-03-16
K102244RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2010-12-03
K040049THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2004-12-17
K860704THE KEYMED SIGMOIDOSCOPE DISINFECTION STANDKeymed, Inc.1986-06-17
K841331OLYMPUS KC-10 MOBILE DISINFEC-STATKeymed, Inc.1984-07-19