Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171208
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K171208
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
Visionsense Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz 49348 IL
Other 510(k) Applications for this Company
Contact
Alex Chanin
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2017
Decision Date
02/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact