Apparatus, Exhaust, Surgical

FDA product code FYD · 73 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5070
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1985-02-27 – 2024-08-05

FYD 2024-08-05

PlumeSafe X5 Smoke Management System

Applicant Conmed Corporation

K number K240127

View details →

FYD 2024-04-10

8Q10 Surclear Smoke Plume Evacuation System

Applicant Surnic Corporation

K number K233789

View details →

FYD 2022-01-03

Medline Smoke Evacuation Shroud

Applicant Medline Industries, Inc.

K number K213068

View details →

FYD 2021-03-25

NEBULAE SRS Laparoscopic Surgical Smoke Removal System

Applicant Northgate Technologies, Inc.

K number K202944

View details →

FYD 2020-06-26

Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

Applicant Megadyne Medical Products, Inc.

K number K200250

View details →

FYD 2019-08-29

EvaQMax Smoke Evacuation System

Applicant Bio Protech, Inc.

K number K192035

View details →

FYD 2019-07-26

Megadyne Foot Switch

Applicant Megadyne Medical Products, Inc.

K number K191328

View details →

FYD 2019-02-07

SafeAir Smoke Evacuator compact

Applicant Lina Medical Aps

K number K182224

View details →

FYD 2018-05-18

Smoklean

Applicant Sejong Medical Co., Ltd.

K number K173108

View details →

FYD 2017-10-30

Crystal Vision

Applicant I.C Medical, Inc.

K number K163659

View details →

FYD 2009-05-05

CONMED AER DEFENSE SMOKE EVACUATOR

Applicant Conmed Corporation

K number K091139

View details →

FYD 2006-06-06

SERVICE MANAGER SM40SE

Applicant Conmed Integrated Systems, Canada, Ulc

K number K053464

View details →

FYD 2006-02-13

LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM

Applicant Medtek Devices, Inc.

K number K052797

View details →

FYD 2005-10-04

MASTEL LASER CLEAN ROOM, MODEL EBS-100

Applicant Mastel Precision Surgical Instruments, Inc.

K number K043494

View details →

FYD 2004-05-07

LAFACI

Applicant Vision Pro, LLC

K number K032400

View details →

FYD 2002-05-03

SMOKE EVACUATION HOSES/TUBING

Applicant Dm Medical, Inc.

K number K020510

View details →

FYD 2001-11-29

NEPTUNE WASTE MANAGEMENT STSTEM

Applicant Stryker Instruments

K number K012991

View details →

FYD 2001-02-01

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES

Applicant I.C Medical, Inc.

K number K003840

View details →

FYD 2000-06-15

STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

Applicant Stackhouse, Inc.

K number K001082

View details →

FYD 2000-06-08

PENADAPT 10

Applicant Buffalo Filter Co., Inc.

K number K000904

View details →

FYD 1999-08-24

NEPTUNE WASTE MANAGEMENT SYSTEM

Applicant American Immuno Tech

K number K990037

View details →

FYD 1999-08-20

PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1

Applicant Pall Medical

K number K992361

View details →

FYD 1999-08-16

BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF

Applicant Buffalo Filter Co., Inc.

K number K983298

View details →

FYD 1999-08-11

BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801

Applicant Buffalo Filter Co., Inc.

K number K983364

View details →

FYD 1999-08-11

BUFFALO FILTER VIROSAFE HRF- #VSHRFO1

Applicant Buffalo Filter Co., Inc.

K number K983333

View details →

FYD 1999-06-03

STERIS SMOKE EVACUATION SYSTEM

Applicant STERIS Corporation

K number K991167

View details →

FYD 1998-06-29

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

Applicant Valleylab, Inc.

K number K980915

View details →

FYD 1997-12-19

SKYVAL

Applicant Pyramid Air Systems

K number K973610

View details →

FYD 1997-11-04

SMARTVAC SMOKE EVACUATION SYSTEM

Applicant Isomedix Operations, Inc.

K number K970352

View details →

FYD 1995-08-28

FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC

Applicant Utah Medical Products, Inc.

K number K952981

View details →

FYD 1995-07-10

BUFFALO FILTER REPLACEMENT FILTER #BSPF030

Applicant Buffalo Filter Co., Inc.

K number K943226

View details →

FYD 1995-07-07

BUFFALO FILTER REPLACEMENT FILTER #BSUCF03

Applicant Buffalo Filter Co., Inc.

K number K943227

View details →

FYD 1994-03-24

BEI MEDICAL SYSTEMS' SMOKE EVACUATOR

Applicant Bei Medical Systems Co., Inc.

K number K940266

View details →

FYD 1994-03-07

SNJ SMOKE EVACUATION SUCTION WAND

Applicant Lca, Inc.

K number K935439

View details →

FYD 1994-02-18

CRYSTAL VISION AND ACCESSORIES

Applicant I.C Medical, Inc.

K number K932230

View details →

FYD 1994-02-09

ACU-EVAC

Applicant Acuderm, Inc.

K number K930043

View details →

FYD 1993-11-30

REUSABLE TOWEL AND GOWN PACKS

Applicant Custom Sterile Services, Inc.

K number K930167

View details →

FYD 1993-11-30

BUFFALO FILTER REPLACEMENT FILTER #BST300UL

Applicant Buffalo Filter Co., Inc.

K number K930062

View details →

FYD 1993-11-30

BUFFALO FILTER REPLACEMENT FILTER #BPTU100

Applicant Buffalo Filter Co., Inc.

K number K930058

View details →

FYD 1993-11-16

PLUMEMASTER SMOKE EVACUATION SYSTEM

Applicant Sorenson Laboratories, Inc.

K number K930434

View details →

FYD 1993-11-12

BUFFALO FILTER REPLACEMENT FILTER #BCCHAR

Applicant Buffalo Filter Co., Inc.

K number K930066

View details →

FYD 1993-11-12

BUFFALO FILTER REPLACEMENT FILTER #BCR0043

Applicant Buffalo Filter Co., Inc.

K number K930065

View details →

FYD 1993-11-12

BUFFALO FILTER REPLACEMENT FILTER #BCR0030

Applicant Buffalo Filter Co., Inc.

K number K930064

View details →

FYD 1993-11-12

BUFFALO FILTER REPLACEMENT FILTER #BCULPA

Applicant Buffalo Filter Co., Inc.

K number K930063

View details →

FYD 1993-11-12

BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO

Applicant Buffalo Filter Co., Inc.

K number K930060

View details →

FYD 1993-11-03

VICROSAFE 6 AND VICROSAFE 12

Applicant Buffalo Filter Co., Inc.

K number K930041

View details →

FYD 1993-11-02

BUFFALO FILTER REPLACEMENT FILTER BST312PF

Applicant Buffalo Filter Co., Inc.

K number K930061

View details →

FYD 1993-11-02

BUFFALO FILTER REPLACEMENT #BLFS-101/103

Applicant Buffalo Filter Co., Inc.

K number K930040

View details →

FYD 1993-10-29

BUFFALO FILTER REPLACEMENT FILTER #BILF-100

Applicant Buffalo Filter Co., Inc.

K number K930450

View details →

FYD 1993-10-29

BUFFALO FILTER REPLACEMENT FILTER #BSTM300

Applicant Buffalo Filter Co., Inc.

K number K930059

View details →

FYD 1993-09-13

PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM

Applicant Buffalo Filter Co., Inc.

K number K924732

View details →

FYD 1993-09-13

PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM

Applicant Buffalo Filter Co., Inc.

K number K924731

View details →

FYD 1993-03-24

QUINEVAC II

Applicant Recto Molded Products, Inc.

K number K920629

View details →

FYD 1993-01-29

SMOKE EATER

Applicant Nordex Medical Corp.

K number K923799

View details →

FYD 1993-01-06

ENVIROMATE(TM) SMOKE EVACUATION SYSTEM

Applicant Lase, Inc.

K number K922555

View details →

FYD 1992-10-01

SRH-678 VACCUUM TUBING

Applicant Quinn Healthcare Products

K number K920210

View details →

FYD 1992-10-01

CRF CHARCOAL CANISTER REPLACEMENT FILTER

Applicant Quinn Healthcare Products

K number K920209

View details →

FYD 1992-08-12

HPM REPLACEMENT ULPA FILTER MODEL UF001

Applicant Hpm Ent.

K number K920371

View details →

FYD 1992-02-12

I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR

Applicant I.C Medical, Inc.

K number K914118

View details →

FYD 1991-11-01

SMOKE/ODOR EVACUATOR #757

Applicant Olsen Electrosurgical, Inc.

K number K912612

View details →

FYD 1991-09-23

BIPURE 1000

Applicant Laser Engineering, Inc.

K number K912347

View details →

FYD 1991-09-06

PLUME MASTER

Applicant Sorex Medical

K number K913036

View details →

FYD 1991-08-20

PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)

Applicant Precision Laser Products, Inc.

K number K912853

View details →

FYD 1991-08-12

SURG/ASSIST MODEL SA-1

Applicant Surg-Assist, Inc.

K number K912422

View details →

FYD 1991-07-26

SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200

Applicant Sun Medical, Inc.

K number K911154

View details →

FYD 1991-07-08

AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM

Applicant Stackhouse Assoc.

K number K912651

View details →

FYD 1990-08-17

I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR

Applicant I.C Medical, Inc.

K number K902611

View details →

FYD 1990-01-11

SURGISMOKE

Applicant Spectro Industries, Inc.

K number K896822

View details →

FYD 1989-09-28

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100

Applicant Laser Industries , Ltd.

K number K894765

View details →

FYD 1989-09-28

PLUME-AWAY SMOKE EVACUATION SYSTEM

Applicant Laser Technologies Group, Inc.

K number K894038

View details →

FYD 1988-05-11

THE S.A.F.E. SYSTEM

Applicant Pfizer Laser Systems

K number K880890

View details →

FYD 1988-01-27

MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM

Applicant Stackhouse Assoc.

K number K874512

View details →

FYD 1985-02-27

XANAR MODEL XSE-300 SMOKE EVACULATER

Applicant Xanar, Inc.

K number K844087

View details →