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
Cleared
Aug 16, 1999
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
Buffalo Filter Co., Inc.
General Hospital
329d
Cleared
Aug 11, 1999
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
Buffalo Filter Co., Inc.
General Hospital
322d
Cleared
Aug 11, 1999
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
Buffalo Filter Co., Inc.
General Hospital
321d
Cleared
Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
STERIS Corporation
General Hospital
57d
Cleared
Jun 29, 1998
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
Valleylab, Inc.
General Hospital
110d
Cleared
Dec 19, 1997
SKYVAL
Pyramid Air Systems
General Hospital
88d
Cleared
Nov 04, 1997
SMARTVAC SMOKE EVACUATION SYSTEM
Isomedix Operations, Inc.
General Hospital
278d
Cleared
Aug 28, 1995
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
Utah Medical Products, Inc.
General Hospital
61d
Cleared
Jul 10, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
Buffalo Filter Co., Inc.
General Hospital
369d
Cleared
Jul 07, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
Buffalo Filter Co., Inc.
General Hospital
366d
Cleared
Mar 24, 1994
BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
Bei Medical Systems Co., Inc.
General Hospital
62d
Cleared
Mar 07, 1994
SNJ SMOKE EVACUATION SUCTION WAND
Lca, Inc.
General Hospital
115d
Cleared
Feb 18, 1994
CRYSTAL VISION AND ACCESSORIES
I.C Medical, Inc.
General Hospital
287d
Cleared
Feb 09, 1994
ACU-EVAC
Acuderm, Inc.
General Hospital
400d
Cleared
Nov 30, 1993
BUFFALO FILTER REPLACEMENT FILTER #BPTU100
Buffalo Filter Co., Inc.
General Hospital
328d
Cleared
Nov 30, 1993
BUFFALO FILTER REPLACEMENT FILTER #BST300UL
Buffalo Filter Co., Inc.
General Hospital
328d
Cleared
Nov 30, 1993
REUSABLE TOWEL AND GOWN PACKS
Custom Sterile Services, Inc.
General Hospital
321d
Cleared
Nov 16, 1993
PLUMEMASTER SMOKE EVACUATION SYSTEM
Sorenson Laboratories, Inc.
General Hospital
294d
Cleared
Nov 12, 1993
BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
Buffalo Filter Co., Inc.
General Hospital
310d
Cleared
Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCULPA
Buffalo Filter Co., Inc.
General Hospital
310d
Cleared
Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0030
Buffalo Filter Co., Inc.
General Hospital
310d
Cleared
Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0043
Buffalo Filter Co., Inc.
General Hospital
310d
Cleared
Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCCHAR
Buffalo Filter Co., Inc.
General Hospital
310d
Cleared
Nov 03, 1993
VICROSAFE 6 AND VICROSAFE 12
Buffalo Filter Co., Inc.
General Hospital
302d