Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K222901
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K222901
Device Name
Insufflator, Laparoscopic
Applicant
Palliare Ltd.
Galway Business Park, Dangan
Galway H91 P2DK IE
Other 510(k) Applications for this Company
Contact
John O'Dea
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2022
Decision Date
01/27/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact