FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
SafeAir Smoke Pencil
K Number: K143145
·
Decision Dec 4, 2014
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
16
Review Days
31
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Basic Information
- Device Name
- SafeAir Smoke Pencil
- K Number
- K143145
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lina Medical Aps
- Date Received
- November 3, 2014
- Decision Date
- December 4, 2014
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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| 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 |
| K182224 | SafeAir Smoke Evacuator compact | Feb 7, 2019 | 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 |
| 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 |