510(k) K230239

AirSeal iFS System; AirSeal dV Solution by Conmed Corporation — Product Code HIF

K230239 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "AirSeal iFS System; AirSeal dV Solution". The FDA issued a decision of Substantially Equivalent on September 20, 2023. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
January 30, 2023
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