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510(k) K170757

Device
Aegis Transit System
Applicant
Boston-Biomedical Associates
510(k) number
K170757
Product code
EWY  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-14
Date received
2017-03-13
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
Lauren Baker
Address
100 Crowley Dr. Suite 216 Malborough MA US 01752 01752

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
K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.2022-06-23
K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc.2021-05-11
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#

summary

FDA Review#

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