510(k) K132203

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA by Lexion Medical, LLC — Product Code HIF

K132203 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA". The FDA issued a decision of Substantially Equivalent on September 20, 2013. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Lexion Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2013
Date Received
July 16, 2013
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