Product code FYD
- Device name
- Apparatus, Exhaust, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5070
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024-08-05 |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024-04-10 |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | 2022-01-03 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021-03-25 |
| 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 |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | 2019-08-29 |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019-07-26 |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019-02-07 |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | 2018-05-18 |
| K163659 | Crystal Vision | I.C Medical, Inc. | 2017-10-30 |
| K142335 | RapidVac Smoke Evacuator System | Covidien | 2015-01-14 |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 2014-03-03 |
| K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | Conmed Corporation | 2009-05-05 |
| K053464 | SERVICE MANAGER SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006-06-06 |
| K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | Medtek Devices, Inc. | 2006-02-13 |
| K043494 | MASTEL LASER CLEAN ROOM, MODEL EBS-100 | Mastel Precision Surgical Instruments, Inc. | 2005-10-04 |
| K032400 | LAFACI | Vision Pro, LLC | 2004-05-07 |
| K020510 | SMOKE EVACUATION HOSES/TUBING | Dm Medical, Inc. | 2002-05-03 |
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM | Stryker Instruments | 2001-11-29 |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | I.C Medical, Inc. | 2001-02-01 |
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 | Stackhouse, Inc. | 2000-06-15 |
| K000904 | PENADAPT 10 | Buffalo Filter Co., Inc. | 2000-06-08 |
| K990037 | NEPTUNE WASTE MANAGEMENT SYSTEM | American Immuno Tech | 1999-08-24 |
| K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 | Pall Medical | 1999-08-20 |
| K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF | Buffalo Filter Co., Inc. | 1999-08-16 |
| K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | Buffalo Filter Co., Inc. | 1999-08-11 |
| K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 | Buffalo Filter Co., Inc. | 1999-08-11 |
| K991167 | STERIS SMOKE EVACUATION SYSTEM | STERIS Corporation | 1999-06-03 |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Valleylab, Inc. | 1998-06-29 |
| K973610 | SKYVAL | Pyramid Air Systems | 1997-12-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705036046523 | Megadyne | ETHICON ENDO-SURGERY, LLC | 2026-05-27 |
| 10193489085341 | Medline | MEDLINE INDUSTRIES, INC. | 2023-02-22 |
| 10193489085358 | Medline | MEDLINE INDUSTRIES, INC. | 2023-02-22 |
| 07613327466324 | Neptune | STRYKER CORPORATION | 2019-10-17 |
| 10609960000739 | Geiger Viral Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2018-07-10 |
| 10609960001026 | OB/GYN FILTER PACK | DERMATOLOGIC LAB AND SUPPLY, INC. | 2018-07-10 |
| 10609960000746 | Geiger Viral Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2017-03-29 |
| 10614559103739 | Ultra Vac | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559103722 | Ultra Vac | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559103005 | Megadyne | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102992 | Megadyne | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102787 | Attacha Vac | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559104187 | ZIP Pen | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559104040 | ZIP Pen | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102091 | Mega Vac Plus | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102084 | SPECULUM TUBING | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102077 | LAPAROSCOPIC TUBING | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559102008 | Attacha Vac | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 10614559101988 | Ultra Vac | MEGADYNE MEDICAL PRODUCTS, INC. | 2016-12-14 |
| 07613327299328 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299304 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299267 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299250 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299243 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299236 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613154495597 | NA | STRYKER CORPORATION | 2016-09-23 |
| 10609960000579 | Geiger Smoke Evacuator Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2016-07-14 |
| 10609960000555 | Geiger Smoke Evacuator Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2016-07-14 |
| 10609960000548 | Geiger Smoke Evacuator Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2016-07-14 |
| 10609960000531 | Geiger Smoke Evacuator Filter | DERMATOLOGIC LAB AND SUPPLY, INC. | 2016-07-14 |