Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210353
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K210353
Device Name
Endoscope Channel Accessory
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Kyra McNamara
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2021
Decision Date
05/06/2021
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact