FDA Product Code
FDA Product Code FYD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5070
510(k) Clearances — 75 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024-08-05 | Traditional | PDF ↗ |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024-04-10 | Traditional | PDF ↗ |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | 2022-01-03 | Traditional | PDF ↗ |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021-03-25 | Traditional | PDF ↗ |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | Megadyne Medical Products, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | 2019-08-29 | Traditional | PDF ↗ |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019-07-26 | Traditional | PDF ↗ |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019-02-07 | Traditional | PDF ↗ |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | 2018-05-18 | Traditional | PDF ↗ |
| K163659 | Crystal Vision | I.C Medical, Inc. | 2017-10-30 | Special | PDF ↗ |
| K142335 | RapidVac Smoke Evacuator System | Covidien | 2015-01-14 | Traditional | PDF ↗ |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 2014-03-03 | Traditional | PDF ↗ |
| K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | Conmed Corporation | 2009-05-05 | Traditional | PDF ↗ |
| K053464 | SERVICE MANAGER SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006-06-06 | Traditional | PDF ↗ |
| K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | Medtek Devices, Inc. | 2006-02-13 | Traditional | PDF ↗ |
| K043494 | MASTEL LASER CLEAN ROOM, MODEL EBS-100 | Mastel Precision Surgical Instruments, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K032400 | LAFACI | Vision Pro, LLC | 2004-05-07 | Traditional | PDF ↗ |
| K020510 | SMOKE EVACUATION HOSES/TUBING | Dm Medical, Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM | Stryker Instruments | 2001-11-29 | Traditional | PDF ↗ |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | I.C Medical, Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 | Stackhouse, Inc. | 2000-06-15 | Traditional | PDF ↗ |
| K000904 | PENADAPT 10 | Buffalo Filter Co., Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K990037 | NEPTUNE WASTE MANAGEMENT SYSTEM | American Immuno Tech | 1999-08-24 | Traditional | PDF ↗ |
| K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 | Pall Medical | 1999-08-20 | Traditional | PDF ↗ |
| K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF | Buffalo Filter Co., Inc. | 1999-08-16 | Traditional | PDF ↗ |
| K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 | Buffalo Filter Co., Inc. | 1999-08-11 | Traditional | PDF ↗ |
| K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | Buffalo Filter Co., Inc. | 1999-08-11 | Traditional | PDF ↗ |
| K991167 | STERIS SMOKE EVACUATION SYSTEM | STERIS Corporation | 1999-06-03 | Abbreviated | PDF ↗ |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Valleylab, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K973610 | SKYVAL | Pyramid Air Systems | 1997-12-19 | Traditional | PDF ↗ |
| K970352 | SMARTVAC SMOKE EVACUATION SYSTEM | Isomedix Operations, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC | Utah Medical Products, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K943226 | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 | Buffalo Filter Co., Inc. | 1995-07-10 | Traditional | PDF ↗ |
| K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 | Buffalo Filter Co., Inc. | 1995-07-07 | Traditional | PDF ↗ |
| K940266 | BEI MEDICAL SYSTEMS' SMOKE EVACUATOR | Bei Medical Systems Co., Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K935439 | SNJ SMOKE EVACUATION SUCTION WAND | Lca, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K932230 | CRYSTAL VISION AND ACCESSORIES | I.C Medical, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K930043 | ACU-EVAC | Acuderm, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K930167 | REUSABLE TOWEL AND GOWN PACKS | Custom Sterile Services, Inc. | 1993-11-30 | Traditional | PDF ↗ |
| K930058 | BUFFALO FILTER REPLACEMENT FILTER #BPTU100 | Buffalo Filter Co., Inc. | 1993-11-30 | Traditional | PDF ↗ |
| K930062 | BUFFALO FILTER REPLACEMENT FILTER #BST300UL | Buffalo Filter Co., Inc. | 1993-11-30 | Traditional | PDF ↗ |
| K930434 | PLUMEMASTER SMOKE EVACUATION SYSTEM | Sorenson Laboratories, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K930066 | BUFFALO FILTER REPLACEMENT FILTER #BCCHAR | Buffalo Filter Co., Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930064 | BUFFALO FILTER REPLACEMENT FILTER #BCR0030 | Buffalo Filter Co., Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930063 | BUFFALO FILTER REPLACEMENT FILTER #BCULPA | Buffalo Filter Co., Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930060 | BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO | Buffalo Filter Co., Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930065 | BUFFALO FILTER REPLACEMENT FILTER #BCR0043 | Buffalo Filter Co., Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930041 | VICROSAFE 6 AND VICROSAFE 12 | Buffalo Filter Co., Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K930040 | BUFFALO FILTER REPLACEMENT #BLFS-101/103 | Buffalo Filter Co., Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K930061 | BUFFALO FILTER REPLACEMENT FILTER BST312PF | Buffalo Filter Co., Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K930450 | BUFFALO FILTER REPLACEMENT FILTER #BILF-100 | Buffalo Filter Co., Inc. | 1993-10-29 | Traditional | PDF ↗ |
| K930059 | BUFFALO FILTER REPLACEMENT FILTER #BSTM300 | Buffalo Filter Co., Inc. | 1993-10-29 | Traditional | PDF ↗ |
| K924731 | PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K924732 | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K920629 | QUINEVAC II | Recto Molded Products, Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K923799 | SMOKE EATER | Nordex Medical Corp. | 1993-01-29 | Traditional | PDF ↗ |
| K922555 | ENVIROMATE(TM) SMOKE EVACUATION SYSTEM | Lase, Inc. | 1993-01-06 | Traditional | PDF ↗ |
| K920209 | CRF CHARCOAL CANISTER REPLACEMENT FILTER | Quinn Healthcare Products | 1992-10-01 | Traditional | PDF ↗ |
| K920210 | SRH-678 VACCUUM TUBING | Quinn Healthcare Products | 1992-10-01 | Traditional | PDF ↗ |
| K920371 | HPM REPLACEMENT ULPA FILTER MODEL UF001 | Hpm Ent. | 1992-08-12 | Traditional | PDF ↗ |
| K914118 | I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR | I.C Medical, Inc. | 1992-02-12 | Traditional | PDF ↗ |
| K912612 | SMOKE/ODOR EVACUATOR #757 | Olsen Electrosurgical, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K912347 | BIPURE 1000 | Laser Engineering, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K913036 | PLUME MASTER | Sorex Medical | 1991-09-06 | Traditional | PDF ↗ |
| K912853 | PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) | Precision Laser Products, Inc. | 1991-08-20 | Traditional | PDF ↗ |
| K912422 | SURG/ASSIST MODEL SA-1 | Surg-Assist, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | Sun Medical, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K912651 | AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM | Stackhouse Assoc. | 1991-07-08 | Traditional | PDF ↗ |
| K902611 | I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR | I.C Medical, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K896822 | SURGISMOKE | Spectro Industries, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K894765 | SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 | Laser Industries , Ltd. | 1989-09-28 | Traditional | PDF ↗ |
| K894038 | PLUME-AWAY SMOKE EVACUATION SYSTEM | Laser Technologies Group, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K880890 | THE S.A.F.E. SYSTEM | Pfizer Laser Systems | 1988-05-11 | Traditional | PDF ↗ |
| K874512 | MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM | Stackhouse Assoc. | 1988-01-27 | Traditional | PDF ↗ |
| K844087 | XANAR MODEL XSE-300 SMOKE EVACULATER | Xanar, Inc. | 1985-02-27 | Traditional | PDF ↗ |
Product code FYD · Class II · General, Plastic Surgery. Data: openFDA.