Smoklean
FDA 510(k) K173108 · Sejong Medical Co., Ltd.
510(k) numberK173108
Submission
- Device name
- Smoklean
- Applicant
- Sejong Medical Co., Ltd.
Paju-Si, KR - Received
- September 29, 2017
- Decision date
- May 18, 2018
- 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 |
| K163659 | Crystal VisionFYD · Special | I.C Medical, Inc. | 10/30/2017SE |
| K142335 | RapidVac Smoke Evacuator SystemFYD · Traditional | Covidien | 01/14/2015SE |
More from Covidien
| 510(k) | Device | Decision |
|---|---|---|
| K253165 | LAP-iX2NGEI · Traditional | 06/09/2026SE |
| K252985 | LaportGCJ · Traditional | 05/19/2026SE |
| K200639 | LAP-iXGEI · Traditional | 09/29/2021SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | 04/03/2020SE |
| K173111 | LAP-iX Suction IrrigationHET · Traditional | 11/28/2017SE |
| K173112 | LAP-iXGEI · Traditional | 11/21/2017SE |
| K171726 | LapBagGCJ · Traditional | 09/25/2017SE |
| K171741 | LaportGCJ · Traditional | 08/29/2017SE |
Questions and answers
When was Smoklean cleared by the FDA?
Smoklean (K173108) received a 510(k) decision of Substantially Equivalent on May 18, 2018, 231 days after the submission was received.
What is the product code of K173108?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.