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FDA 510(k) Application Details - K180165
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K180165
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
EMcision Ltd.
DuCane Road
London W12 0HS GB
Other 510(k) Applications for this Company
Contact
Francois Poulin
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2018
Decision Date
03/20/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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