Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K212054
Device Classification Name
System,Surgical,Computer Controlled Instrument
More FDA Info for this Device
510(K) Number
K212054
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
Asensus Surgical, Inc.
1 TW Alexander Drive, Suite 160
Durham, NC 27703 US
Other 510(k) Applications for this Company
Contact
Taylor Fisher
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
NAY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2021
Decision Date
08/30/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact