FDA.reportPublic FDA data

510(k) K241168

Device
System 83 Revolve Endoscope Washer/Disinfector
Applicant
Wassenburg Medical, Inc.
510(k) number
K241168
Product code
FEB
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-19
Date received
2024-04-26
Regulation
876.1500
Classification name
Accessories, Cleaning, For Endoscope
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
Mario Infanti
Address
144 Railroad Dr. Ivyland PA US 18974 18974

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation2024-12-02
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