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 Stackhouse Assoc..
75
Total
75
Cleared
194d
Avg days
1985
Since
75 devices
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
Mar 24, 1993
QUINEVAC II
Recto Molded Products, Inc.
General Hospital
406d
Cleared
Jan 29, 1993
SMOKE EATER
Nordex Medical Corp.
General Hospital
184d
Cleared
Jan 06, 1993
ENVIROMATE(TM) SMOKE EVACUATION SYSTEM
Lase, Inc.
General Hospital
222d
Cleared
Oct 01, 1992
CRF CHARCOAL CANISTER REPLACEMENT FILTER
Quinn Healthcare Products
General Hospital
259d
Cleared
Oct 01, 1992
SRH-678 VACCUUM TUBING
Quinn Healthcare Products
General Hospital
259d
Cleared
Aug 12, 1992
HPM REPLACEMENT ULPA FILTER MODEL UF001
Hpm Ent.
General Hospital
197d
Cleared
Feb 12, 1992
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
I.C Medical, Inc.
General Hospital
152d
Cleared
Nov 01, 1991
SMOKE/ODOR EVACUATOR #757
Olsen Electrosurgical, Inc.
General Hospital
142d
Cleared
Sep 23, 1991
BIPURE 1000
Laser Engineering, Inc.
General Hospital
118d
Cleared
Sep 06, 1991
PLUME MASTER
Sorex Medical
General Hospital
59d
Cleared
Aug 20, 1991
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
Precision Laser Products, Inc.
General Hospital
53d
Cleared
Aug 12, 1991
SURG/ASSIST MODEL SA-1
Surg-Assist, Inc.
General Hospital
73d
Cleared
Jul 26, 1991
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
Sun Medical, Inc.
General Hospital
133d
Cleared
Jul 08, 1991
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
Stackhouse Assoc.
General Hospital
21d
Cleared
Aug 17, 1990
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
I.C Medical, Inc.
General Hospital
65d
Cleared
Jan 11, 1990
SURGISMOKE
Spectro Industries, Inc.
General Hospital
38d
Cleared
Sep 28, 1989
PLUME-AWAY SMOKE EVACUATION SYSTEM
Laser Technologies Group, Inc.
General Hospital
114d
Cleared
Sep 28, 1989
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
Laser Industries , Ltd.
General Hospital
64d