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 Stackhouse Assoc..

75
Total
75
Cleared
194d
Avg days
1985
Since
75 devices
49–72 of 75
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 Mar 24, 1993
QUINEVAC II
K920629
Recto Molded Products, Inc.
General Hospital · 406d
Cleared Jan 29, 1993
SMOKE EATER
K923799
Nordex Medical Corp.
General Hospital · 184d
Cleared Jan 06, 1993
ENVIROMATE(TM) SMOKE EVACUATION SYSTEM
K922555
Lase, Inc.
General Hospital · 222d
Cleared Oct 01, 1992
CRF CHARCOAL CANISTER REPLACEMENT FILTER
K920209
Quinn Healthcare Products
General Hospital · 259d
Cleared Oct 01, 1992
SRH-678 VACCUUM TUBING
K920210
Quinn Healthcare Products
General Hospital · 259d
Cleared Aug 12, 1992
HPM REPLACEMENT ULPA FILTER MODEL UF001
K920371
Hpm Ent.
General Hospital · 197d
Cleared Feb 12, 1992
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
K914118
I.C Medical, Inc.
General Hospital · 152d
Cleared Nov 01, 1991
SMOKE/ODOR EVACUATOR #757
K912612
Olsen Electrosurgical, Inc.
General Hospital · 142d
Cleared Sep 23, 1991
BIPURE 1000
K912347
Laser Engineering, Inc.
General Hospital · 118d
Cleared Sep 06, 1991
PLUME MASTER
K913036
Sorex Medical
General Hospital · 59d
Cleared Aug 20, 1991
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
K912853
Precision Laser Products, Inc.
General Hospital · 53d
Cleared Aug 12, 1991
SURG/ASSIST MODEL SA-1
K912422
Surg-Assist, Inc.
General Hospital · 73d
Cleared Jul 26, 1991
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
K911154
Sun Medical, Inc.
General Hospital · 133d
Cleared Jul 08, 1991
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
K912651
Stackhouse Assoc.
General Hospital · 21d
Cleared Aug 17, 1990
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
K902611
I.C Medical, Inc.
General Hospital · 65d
Cleared Jan 11, 1990
SURGISMOKE
K896822
Spectro Industries, Inc.
General Hospital · 38d
Cleared Sep 28, 1989
PLUME-AWAY SMOKE EVACUATION SYSTEM
K894038
Laser Technologies Group, Inc.
General Hospital · 114d
Cleared Sep 28, 1989
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
K894765
Laser Industries , Ltd.
General Hospital · 64d