510(k) K914118

I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR by I.C Medical, Inc. — Product Code FYD

K914118 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR". The FDA issued a decision of Substantially Equivalent on February 12, 1992. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1992
Date Received
September 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type