510(k) K060723

40 L HIGH FLOW INSUFFLATOR F113 by W.O.M. World of Medicine AG — Product Code HIF

K060723 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine AG for the device "40 L HIGH FLOW INSUFFLATOR F113". The FDA issued a decision of Substantially Equivalent on May 25, 2006. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. W.O.M. World of Medicine AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2006
Date Received
March 17, 2006
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