Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K212323
Device Classification Name
More FDA Info for this Device
510(K) Number
K212323
Device Name
Instinct Plus Endoscopic Clipping Device
Applicant
Wilson-Cook Medical Inc.
4900 Bethania Station Road
Winston-Salem, NC 27105 US
Other 510(k) Applications for this Company
Contact
Scottie Fariole
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2021
Decision Date
08/25/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact