FDA.report

510(k) K243433

Device
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
Applicant
STERIS Corporation
510(k) number
K243433
Product code
FEB
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2024-11-05
Regulation
876.1500
Classification name
Accessories, Cleaning, For Endoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jennifer Nalepka
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 FEB

510(k)DeviceApplicantDecision date
K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.2024-12-19
K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation2023-06-30
K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.2022-01-14
K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.2020-09-01
K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.2020-03-30
K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.2019-07-09
K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorAdvanced Sterilization Products (Asp)2019-04-23
K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation2018-12-14
K172677Advantage Plus Pass-ThruMedivators, Inc.2017-12-19
K162120Scope-Assist Flushing SinkCustom Ultrasonics, Inc.2017-04-28
K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc.2016-12-21
K152189EVOTECH ECRAdvanced Sterilization Products (Asp)2016-07-20
K140977EVOTECH ECRAdvanced Sterilization Products2014-12-22
K122172SYSTEM 83 PLUSCustom Ultrasonics2013-01-25
K120357ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp.2012-12-20