Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K223705
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K223705
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
Covidien LLC
3062 Bunker Hill Lane
Santa Clara, CA 95054 US
Other 510(k) Applications for this Company
Contact
Liron Bar Yaakov
Other 510(k) Applications for this Contact
Regulation Number
876.1725
More FDA Info for this Regulation Number
Classification Product Code
FFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2022
Decision Date
04/14/2023
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