Xanar Model XSE-300 Smoke Evaculater
FDA 510(k) K844087 · Xanar, Inc.
510(k) numberK844087
Submission
- Device name
- Xanar Model XSE-300 Smoke Evaculater
- Applicant
- Xanar, Inc.
Colorado Springs, CO, US - Received
- October 22, 1984
- Decision date
- February 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K861688 | Xanar CO2 Surgical Laser System Model XAP-15GEX · Traditional | 10/03/1986SE |
| K852436 | AmbulaseGEX · Traditional | 04/18/1986SE |
| K860496 | Model NY-110 for Upper & Lower (Gu) & PulmonaryLNK · Traditional | 03/14/1986SE |
| K853620 | Model XA-50 - CO2 Surgical LaserGEX · Traditional | 01/24/1986SE |
| K850818 | Co 2 Surgical Laser System NA-120GEX · Traditional | 08/15/1985SE |
| K850805 | Co 2 Surgical Laser System Model NA-40GEX · Traditional | 08/15/1985SE |
| K850804 | Co 2 Surgical Laser System NA-30GEX · Traditional | 08/15/1985SE |
| K841860 | CO2 Surgical Laser System XML-10EWG · Traditional | 11/08/1984SE |
| K833325 | Ambulase XAM-15 Xanar Surg. Laser · Traditional | 01/26/1984SE |
| K837224 | Unknown · Traditional | 05/02/1983SE |
Questions and answers
When was Xanar Model XSE-300 Smoke Evaculater cleared by the FDA?
Xanar Model XSE-300 Smoke Evaculater (K844087) received a 510(k) decision of Substantially Equivalent on February 27, 1985, 128 days after the submission was received.
What is the product code of K844087?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.