510(k) K131402
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