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
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
Feb 18, 1994
CRYSTAL VISION AND ACCESSORIES
I.C Medical, Inc.
General Hospital
287d
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 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
Cleared
Nov 02, 1993
BUFFALO FILTER REPLACEMENT #BLFS-101/103
Buffalo Filter Co., Inc.
General Hospital
301d
Cleared
Nov 02, 1993
BUFFALO FILTER REPLACEMENT FILTER BST312PF
Buffalo Filter Co., Inc.
General Hospital
300d
Cleared
Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BSTM300
Buffalo Filter Co., Inc.
General Hospital
296d
Cleared
Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BILF-100
Buffalo Filter Co., Inc.
General Hospital
297d
Cleared
Sep 13, 1993
PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM
Buffalo Filter Co., Inc.
General Hospital
356d
Cleared
Sep 13, 1993
PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM
Buffalo Filter Co., Inc.
General Hospital
356d
Cleared
Sep 23, 1991
BIPURE 1000
Laser Engineering, Inc.
General Hospital
118d
Cleared
Sep 28, 1989
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
Laser Industries , Ltd.
General Hospital
64d
Cleared
May 11, 1988
THE S.A.F.E. SYSTEM
Pfizer Laser Systems
General Hospital
70d