FYD — Apparatus, Exhaust, Surgical Class II
FDA product code FYD covers "Apparatus, Exhaust, Surgical", a Class II medical device regulated under 21 CFR 878.5070. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |