RapidVac Smoke Evacuator System
FDA 510(k) K142335 · Covidien
510(k) numberK142335
Submission
- Device name
- RapidVac Smoke Evacuator System
- Applicant
- Covidien
Mansfield, MA, US - Received
- August 21, 2014
- Decision date
- January 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYD – Apparatus, Exhaust, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | Conmed Corporation | 08/05/2024SE |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation SystemFYD · Traditional | Surnic Corporation | 04/10/2024SE |
| K213068 | Medline Smoke Evacuation ShroudFYD · Traditional | Medline Industries, Inc. | 01/03/2022SE |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemFYD · Traditional | Northgate Technologies, Inc. | 03/25/2021SE |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable…FYD · Traditional | Megadyne Medical Products, Inc. | 06/26/2020SE |
| K192035 | EvaQMax Smoke Evacuation SystemFYD · Traditional | Bio Protech, Inc. | 08/29/2019SE |
| K191328 | Megadyne Foot SwitchFYD · Traditional | Megadyne Medical Products, Inc. | 07/26/2019SE |
| K182224 | SafeAir Smoke Evacuator compactFYD · Traditional | Lina Medical Aps | 02/07/2019SE |
| K173108 | SmokleanFYD · Traditional | Sejong Medical Co., Ltd. | 05/18/2018SE |
| K163659 | Crystal VisionFYD · Special | I.C Medical, Inc. | 10/30/2017SE |
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Questions and answers
When was RapidVac Smoke Evacuator System cleared by the FDA?
RapidVac Smoke Evacuator System (K142335) received a 510(k) decision of Substantially Equivalent on January 14, 2015, 146 days after the submission was received.
What is the product code of K142335?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.