FDA.report

510(k) K232918

Device
enspire 300 Series Automated Endoscope Reprocessor
Applicant
STERIS Corporation
510(k) number
K232918
Product code
NZA
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-03
Date received
2023-09-19
Regulation
876.1500
Classification name
Accessories, Germicide, Cleaning, For Endoscopes
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nalepka Jennifer
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code NZA

510(k)DeviceApplicantDecision date
K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation2023-07-21
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