510(k) K131402

VISICLEAR SMOKE EVACUATION SYSTEM by Buffalo Filter Co., Inc. — Product Code FYD

K131402 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "VISICLEAR SMOKE EVACUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 3, 2014. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Buffalo Filter Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2014
Date Received
May 15, 2013
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