FYD · Apparatus, Exhaust, Surgical
General, Plastic Surgery · 21 CFR 878.5070 · Class 2
Overview
| Product Code | FYD |
|---|---|
| Device Name | Apparatus, Exhaust, Surgical |
| Regulation | 21 CFR 878.5070 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
Classification Rationale
Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 75)
Showing 20 most recent of 75 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | Aug 5, 2024 | SESE |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | Apr 10, 2024 | SESE |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | Jan 3, 2022 | SESE |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | Mar 25, 2021 | SESE |
| 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. | Jun 26, 2020 | SESE |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | Aug 29, 2019 | SESE |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | Jul 26, 2019 | SESE |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | Feb 7, 2019 | SESE |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | May 18, 2018 | SESE |
| K163659 | Crystal Vision | I.C Medical, Inc. | Oct 30, 2017 | SESE |
| K142335 | RapidVac Smoke Evacuator System | Covidien | Jan 14, 2015 | SESE |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | Mar 3, 2014 | SESE |
| K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | Conmed Corporation | May 5, 2009 | SESE |
| K053464 | SERVICE MANAGER SM40SE | Conmed Integrated Systems, Canada, Ulc | Jun 6, 2006 | SESE |
| K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | Medtek Devices, Inc. | Feb 13, 2006 | SESE |
| K043494 | MASTEL LASER CLEAN ROOM, MODEL EBS-100 | Mastel Precision Surgical Instruments, Inc. | Oct 4, 2005 | SESE |
| K032400 | LAFACI | Vision Pro, LLC | May 7, 2004 | SESE |
| K020510 | SMOKE EVACUATION HOSES/TUBING | Dm Medical, Inc. | May 3, 2002 | SESE |
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM | Stryker Instruments | Nov 29, 2001 | SESE |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | I.C Medical, Inc. | Feb 1, 2001 | SESE |
Top Applicants
- Buffalo Filter Co., Inc. — 21 clearances
- I.C Medical, Inc. — 5 clearances
- Conmed Corporation — 2 clearances
- Megadyne Medical Products, Inc. — 2 clearances
- Quinn Healthcare Products — 2 clearances
