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EWY — Mediastinoscope, Surgical Class II

FDA Device Classification

Classification Details

Product Code
EWY
Device Class
Class II
Regulation Number
874.4720
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K260003karl storz se and co. kgKARL STORZ Mediastinoscopes and InstrumentsMarch 2, 2026
K213194karl storz endoscopy americaHD MediastinoscopeJune 23, 2022
K202272karl storz endoscopy americaHD MediastinoscopeMay 11, 2021
K170757boston-biomedical associatesAegis Transit SystemJuly 14, 2017
K160171aegis surgicalIlluminated Mediastinal Access PortFebruary 26, 2016
K141622aegis surgicalILLUMINATED MEDIASTINOSCOPEJanuary 9, 2015
K971166richard wolf medical instrumentsOPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECEAugust 27, 1997
K954910karl storz endoscopy-americaKARL STORZ OPTICAL MEDIASTINOSCOPENovember 3, 1995
K930215olympusFLEXIBLE TROCAR TUBESMarch 16, 1993
K913829olympusOLYMPUS FLEXIBLE TIP THORACOSCOPENovember 22, 1991
K912362olympusOES THORACOSCOPE SYSTEMOctober 24, 1991