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FDA 510(k) Application Details - K181020
Device Classification Name
Esophagoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K181020
Device Name
Esophagoscope (Flexible Or Rigid)
Applicant
Covidien llc
15 Hampshire Street
Mansfield, MA 02048 US
Other 510(k) Applications for this Company
Contact
Rachel Silva
Other 510(k) Applications for this Contact
Regulation Number
874.4710
More FDA Info for this Regulation Number
Classification Product Code
EOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2018
Decision Date
08/16/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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