FDA.reportPublic FDA data

510(k) K100584

Device
EVIS EXERAII 180 SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
510(k) number
K100584
Product code
NWB  
Decision
Substantially Equivalent (SESE)
Decision date
2010-07-02
Date received
2010-03-02
Regulation
876.1500
Classification name
Endoscope, Accessories, Narrow Band Spectrum
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
STACY A KLUESNER
Address
Regulatory Affairs & Quality 3500 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NWB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.2022-09-08
K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.2022-04-01
K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.2018-09-05
K133538VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NEOlympus Corporation of the Americas2014-08-07
K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LOlympus Winter & Ibe GmbH2009-06-29
K072957EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation2008-03-18
K062049EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation2006-09-22
K051645EVIS EXERA 160A SYSTEMOlympus Medical Systems Corporation2005-10-13

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases