510(k) K211104

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

K211104 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set". The FDA issued a decision of Substantially Equivalent on August 19, 2021. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Conmed Corporation has at least 10 other 510(k) clearances on record.