SafeAir Smoke Evacuator compact
FDA 510(k) K182224 · Lina Medical Aps
510(k) numberK182224
Submission
- Device name
- SafeAir Smoke Evacuator compact
- Applicant
- Lina Medical Aps
Tarnowo Podgorne, PL - Received
- August 16, 2018
- Decision date
- February 7, 2019
- 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
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| K221085 | LiNA OperaScope NeedleFBK · Traditional | 09/02/2022SE |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…HIH · Traditional | 01/17/2020SE |
| K182354 | SafeAir Telescopic Smoke PencilGEI · Traditional | 12/14/2018SE |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…HIH · Traditional | 01/04/2018SE |
| K143145 | SafeAir Smoke PencilGEI · Special | 12/04/2014SE |
| K142757 | LiNA PowerBlade Plus HCGEI · Special | 10/23/2014SE |
| K142538 | LiNA SafeAir Smoke PencilGEI · Special | 10/06/2014SE |
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Questions and answers
When was SafeAir Smoke Evacuator compact cleared by the FDA?
SafeAir Smoke Evacuator compact (K182224) received a 510(k) decision of Substantially Equivalent on February 7, 2019, 175 days after the submission was received.
What is the product code of K182224?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.