FYD — Apparatus, Exhaust, Surgical Class II
FDA Device Classification
Classification Details
- Product Code
- FYD
- Device Class
- Class II
- Regulation Number
- 878.5070
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K240127 | conmed corporation | PlumeSafe X5 Smoke Management System | August 5, 2024 |
| K233789 | surnic corporation | 8Q10 Surclear Smoke Plume Evacuation System | April 10, 2024 |
| K213068 | medline industries | Medline Smoke Evacuation Shroud | January 3, 2022 |
| K202944 | northgate technologies | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | March 25, 2021 |
| K200250 | megadyne medical products | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect | June 26, 2020 |
| K192035 | bio protech | EvaQMax Smoke Evacuation System | August 29, 2019 |
| K191328 | megadyne medical products | Megadyne Foot Switch | July 26, 2019 |
| K182224 | lina medical aps | SafeAir Smoke Evacuator compact | February 7, 2019 |
| K173108 | sejong medical co | Smoklean | May 18, 2018 |
| K163659 | i.c medical | Crystal Vision | October 30, 2017 |
| K142335 | covidien | RapidVac Smoke Evacuator System | January 14, 2015 |
| K131402 | buffalo filter co | VISICLEAR SMOKE EVACUATION SYSTEM | March 3, 2014 |
| K091139 | conmed corporation | CONMED AER DEFENSE SMOKE EVACUATOR | May 5, 2009 |
| K053464 | conmed integrated systems, canada, ulc | SERVICE MANAGER SM40SE | June 6, 2006 |
| K052797 | medtek devices | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | February 13, 2006 |
| K043494 | mastel precision surgical instruments | MASTEL LASER CLEAN ROOM, MODEL EBS-100 | October 4, 2005 |
| K032400 | vision pro | LAFACI | May 7, 2004 |
| K020510 | dm medical | SMOKE EVACUATION HOSES/TUBING | May 3, 2002 |
| K012991 | stryker instruments | NEPTUNE WASTE MANAGEMENT STSTEM | November 29, 2001 |
| K003840 | i.c medical | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | February 1, 2001 |