510(k) K143145 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SafeAir Smoke Pencil
| Applicant | Lina Medical Aps, Glostrup, DK |
| Decision | Substantially Equivalent, Dec 4, 2014 |
| Received | Nov 3, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2025 | Stryker Corporation stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades Open, Classified |
GEI | None listed |
| Jan 6, 2025 | Stryker Corporation 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000)
120V NEPTUNE S ROVER (0711-001-000)
230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG)
230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES) Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by el Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gene Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated b Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gen Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generate Open, Classified |
GEI | None listed |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke genera Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.