FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇱 Poland
SafeAir Smoke Evacuator compact
K Number: K182224
·
Decision Feb 7, 2019
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
16
Review Days
175
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SafeAir Smoke Evacuator compact
- K Number
- K182224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lina Medical Aps
- Date Received
- August 16, 2018
- Decision Date
- February 7, 2019
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYD), ordered by most recent decision date.
PlumeSafe X5 Smoke Management System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8Q10 Surclear Smoke Plume Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Smoke Evacuation Shroud
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EvaQMax Smoke Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Lina Medical Aps
| K Number | Device Name | ||
|---|---|---|---|
| K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | Aug 22, 2024 | Substantially Equivalent |
| K223932 | SafeAir combi (SFR-combi-US) | Apr 26, 2023 | Substantially Equivalent |
| K221085 | LiNA OperaScope Needle | Sep 2, 2022 | Substantially Equivalent |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | Jan 17, 2020 | Substantially Equivalent |
| K182354 | SafeAir Telescopic Smoke Pencil | Dec 14, 2018 | Substantially Equivalent |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | Jan 4, 2018 | Substantially Equivalent |
| K143145 | SafeAir Smoke Pencil | Dec 4, 2014 | Substantially Equivalent |
| K142757 | LiNA PowerBlade Plus HC | Oct 23, 2014 | Substantially Equivalent |
| K142538 | LiNA SafeAir Smoke Pencil | Oct 6, 2014 | Substantially Equivalent |
| K132135 | LINA GOLD LOOP HC | Jan 31, 2014 | Substantially Equivalent |