FYD · Class II · 21 CFR 878.5070

FDA Product Code FYD: Apparatus, Exhaust, Surgical

Smoke evacuation in the operating room protects surgical team members from toxic surgical plume. FDA product code FYD covers surgical exhaust apparatus used to capture and filter electrosurgical and laser smoke.

These devices use suction and filtration to capture surgical plume at the source, preventing inhalation of particulates, viable cellular material, and toxic chemicals released during electrosurgery, laser procedures, and powered bone cutting.

FYD devices are Class II medical devices, regulated under 21 CFR 878.5070 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Buffalo Filter Co., Inc., I.C Medical, Inc. and Megadyne Medical Products, Inc..

75
Total
75
Cleared
194d
Avg days
1985
Since
75 devices
25–48 of 75
Cleared Dec 19, 1997
SKYVAL
K973610
Pyramid Air Systems
General Hospital · 88d
Cleared Nov 04, 1997
SMARTVAC SMOKE EVACUATION SYSTEM
K970352
Isomedix Operations, Inc.
General Hospital · 278d
Cleared Aug 28, 1995
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981
Utah Medical Products, Inc.
General Hospital · 61d
Cleared Jul 10, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943226
Buffalo Filter Co., Inc.
General Hospital · 369d
Cleared Jul 07, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
K943227
Buffalo Filter Co., Inc.
General Hospital · 366d
Cleared Feb 18, 1994
CRYSTAL VISION AND ACCESSORIES
K932230
I.C Medical, Inc.
General Hospital · 287d
Cleared Nov 30, 1993
BUFFALO FILTER REPLACEMENT FILTER #BPTU100
K930058
Buffalo Filter Co., Inc.
General Hospital · 328d
Cleared Nov 30, 1993
BUFFALO FILTER REPLACEMENT FILTER #BST300UL
K930062
Buffalo Filter Co., Inc.
General Hospital · 328d
Cleared Nov 12, 1993
BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
K930060
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCULPA
K930063
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0030
K930064
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0043
K930065
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCCHAR
K930066
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 03, 1993
VICROSAFE 6 AND VICROSAFE 12
K930041
Buffalo Filter Co., Inc.
General Hospital · 302d
Cleared Nov 02, 1993
BUFFALO FILTER REPLACEMENT #BLFS-101/103
K930040
Buffalo Filter Co., Inc.
General Hospital · 301d
Cleared Nov 02, 1993
BUFFALO FILTER REPLACEMENT FILTER BST312PF
K930061
Buffalo Filter Co., Inc.
General Hospital · 300d
Cleared Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BSTM300
K930059
Buffalo Filter Co., Inc.
General Hospital · 296d
Cleared Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BILF-100
K930450
Buffalo Filter Co., Inc.
General Hospital · 297d
Cleared Sep 13, 1993
PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM
K924731
Buffalo Filter Co., Inc.
General Hospital · 356d
Cleared Sep 13, 1993
PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM
K924732
Buffalo Filter Co., Inc.
General Hospital · 356d
Cleared Sep 23, 1991
BIPURE 1000
K912347
Laser Engineering, Inc.
General Hospital · 118d
Cleared Sep 28, 1989
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
K894765
Laser Industries , Ltd.
General Hospital · 64d
Cleared May 11, 1988
THE S.A.F.E. SYSTEM
K880890
Pfizer Laser Systems
General Hospital · 70d