SafeAir Telescopic Smoke Pencil
FDA 510(k) clearance K182354 · decided 2018-12-14
Clearance details
- K-number
- K182354
- Device name
- SafeAir Telescopic Smoke Pencil
- Applicant
- Lina Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2018-08-29
- Decision date
- 2018-12-14
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Glostrup, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lina Medical Aps
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bov recall (Z-1097-2020) | Stryker Instruments Div. of Stryker Corporation | 2020-01-28 |
| Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pen recall (Z-1098-2020) | Stryker Instruments Div. of Stryker Corporation | 2020-01-28 |
| Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil tha recall (Z-1099-2020) | Stryker Instruments Div. of Stryker Corporation | 2020-01-28 |