FDA 510(k) Applications for Medical Device Product Code "FYD"
(Apparatus, Exhaust, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K990037 AMERICAN IMMUNO TECH NEPTUNE WASTE MANAGEMENT SYSTEM 08/24/1999
K192035 Bio Protech, Inc. EvaQMax Smoke Evacuation System 08/29/2019
K983364 BUFFALO FILTER CO., INC. BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 08/11/1999
K983298 BUFFALO FILTER CO., INC. BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF 08/16/1999
K983333 BUFFALO FILTER CO., INC. BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 08/11/1999
K000904 BUFFALO FILTER CO., INC. PENADAPT 10 06/08/2000
K131402 BUFFALO FILTER CO., INC. VISICLEAR SMOKE EVACUATION SYSTEM 03/03/2014
K091139 CONMED CORPORATION CONMED AER DEFENSE SMOKE EVACUATOR 05/05/2009
K053464 CONMED INTEGRATED SYSTEMS, CANADA, ULC SERVICE MANAGER SM40SE 06/06/2006
K142335 COVIDIEN RapidVac Smoke Evacuator System 01/14/2015
K020510 DM MEDICAL INC. SMOKE EVACUATION HOSES/TUBING 05/03/2002
K163659 I.C MEDICAL, INC. Crystal Vision 10/30/2017
K003840 I.C. MEDICAL, INC. CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES 02/01/2001
K970352 ISOMEDIX OPERATIONS INC. SMARTVAC SMOKE EVACUATION SYSTEM 11/04/1997
K182224 LiNA Medical APS SafeAir Smoke Evacuator compact 02/07/2019
K043494 MASTEL PRECISION SURGICAL INSTRUMENTS, INC. MASTEL LASER CLEAN ROOM, MODEL EBS-100 10/04/2005
K213068 Medline Industries, Inc. Medline Smoke Evacuation Shroud 01/03/2022
K052797 MEDTEK DEVICES, INC. LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM 02/13/2006
K191328 Megadyne Medical Products, Inc. Megadyne Foot Switch 07/26/2019
K200250 Megadyne Medical Products, Inc. Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor 06/26/2020
K202944 Northgate Technologies Inc. NEBULAE SRS Laparoscopic Surgical Smoke Removal System 03/25/2021
K992361 PALL MEDICAL PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 08/20/1999
K973610 PYRAMID AIR SYSTEMS SKYVAL 12/19/1997
K173108 Sejong Medical Co., Ltd. Smoklean 05/18/2018
K001082 STACKHOUSE, INC. STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 06/15/2000
K991167 STERIS Corporation STERIS SMOKE EVACUATION SYSTEM 06/03/1999
K012991 STRYKER INSTRUMENTS NEPTUNE WASTE MANAGEMENT STSTEM 11/29/2001
K980915 VALLEYLAB, INC. VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM 06/29/1998
K032400 VISION PRO, L.L.C. LAFACI 05/07/2004


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