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510(k) K213194

Device
HD Mediastinoscope
Applicant
Karl Storz Endoscopy America, Inc.
510(k) number
K213194
Product code
EWY  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-23
Date received
2021-09-29
Regulation
874.4720
Classification name
Mediastinoscope, Surgical
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alita McElroy
Address
2151 E. Grand Ave. El Segundo CA US 90245 90245

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG2026-03-02
K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc.2021-05-11
K170757Aegis Transit SystemBoston-Biomedical Associates2017-07-14
K160171Illuminated Mediastinal Access PortAegis Surgical, Ltd.2016-02-26
K141622ILLUMINATED MEDIASTINOSCOPEAegis Surgical, Ltd.2015-01-09
K971166OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECERichard Wolf Medical Instruments Corp.1997-08-27
K954910KARL STORZ OPTICAL MEDIASTINOSCOPEKARL STORZ Endoscopy-America, Inc.1995-11-03
K930215FLEXIBLE TROCAR TUBESOlympus Corp.1993-03-16
K913829OLYMPUS FLEXIBLE TIP THORACOSCOPEOlympus Corp.1991-11-22
K912362OES THORACOSCOPE SYSTEMOlympus Corp.1991-10-24

Legacy Summary#

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FDA Review#

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