Conmed Aer Defense Smoke Evacuator
FDA 510(k) K091139 · Conmed Corporation
510(k) numberK091139
Submission
- Device name
- Conmed Aer Defense Smoke Evacuator
- Applicant
- Conmed Corporation
Centennial, CO, US - Received
- April 20, 2009
- Decision date
- May 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
More from I.C Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261363 | Y-Knotless Flex AnchorsMBI · Special | 05/13/2026SE |
| K253763 | Y-Knotless Flex AnchorsMBI · Special | 01/29/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | 10/15/2025SE |
| K251530 | CONMED Argo Knotless® AnchorMBI · Special | 06/18/2025SE |
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | 04/07/2025SE |
| K244025 | Argo Knotless GENESYS AnchorMBI · Special | 01/28/2025SE |
| K242187 | BioBrace®OWW · Traditional | 11/27/2024SE |
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | 08/05/2024SE |
| K241906 | BioBrace® Reinforced ImplantOWW · Special | 07/29/2024SE |
| K240090 | Argo Knotless GENESYS AnchorMAI · Traditional | 03/05/2024SE |
Questions and answers
When was Conmed Aer Defense Smoke Evacuator cleared by the FDA?
Conmed Aer Defense Smoke Evacuator (K091139) received a 510(k) decision of Substantially Equivalent on May 5, 2009, 15 days after the submission was received.
What is the product code of K091139?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.