510(k) K211104

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set by Conmed Corporation — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
April 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type