510(k) K182354 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SafeAir Telescopic Smoke Pencil
| Applicant | Lina Medical Aps, Glostrup, DK |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Aug 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2020 | Stryker Instruments Div. of Stryker Corporation Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications Terminated |
GEI | None listed |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation SafeAir Telescopic Smoke
Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | None listed |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation Telescopic Smoke Evac Pencil,
PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | None listed |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation Telescopic Uncoated (Push
Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.