510(k) K894038 ยท FYD Apparatus, Exhaust, Surgical
PLUME-AWAY SMOKE EVACUATION SYSTEM
| Applicant | Laser Technologies Group, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Sep 28, 1989 |
| Received | Jun 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Small, Model Number SQ20012-01 Open, Classified |
FYD | None listed |
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Medium, Model Number SQ20012-02 Open, Classified |
FYD | None listed |
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Large, Model Number SQ20012-03 Open, Classified |
FYD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.