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 Quinn Healthcare Products.

75
Total
75
Cleared
194d
Avg days
1985
Since
75 devices
25–48 of 75
Cleared Aug 16, 1999
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
K983298
Buffalo Filter Co., Inc.
General Hospital · 329d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
K983333
Buffalo Filter Co., Inc.
General Hospital · 322d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K983364
Buffalo Filter Co., Inc.
General Hospital · 321d
Cleared Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
K991167
STERIS Corporation
General Hospital · 57d
Cleared Jun 29, 1998
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915
Valleylab, Inc.
General Hospital · 110d
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 Mar 24, 1994
BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
K940266
Bei Medical Systems Co., Inc.
General Hospital · 62d
Cleared Mar 07, 1994
SNJ SMOKE EVACUATION SUCTION WAND
K935439
Lca, Inc.
General Hospital · 115d
Cleared Feb 18, 1994
CRYSTAL VISION AND ACCESSORIES
K932230
I.C Medical, Inc.
General Hospital · 287d
Cleared Feb 09, 1994
ACU-EVAC
K930043
Acuderm, Inc.
General Hospital · 400d
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 30, 1993
REUSABLE TOWEL AND GOWN PACKS
K930167
Custom Sterile Services, Inc.
General Hospital · 321d
Cleared Nov 16, 1993
PLUMEMASTER SMOKE EVACUATION SYSTEM
K930434
Sorenson Laboratories, Inc.
General Hospital · 294d
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