PLUME-AWAY SMOKE EVACUATION SYSTEM— 510(k) K894038
Substantially EquivalentLaser Technologies Group, Inc.
FDA 510(k) clearance K894038 for PLUME-AWAY SMOKE EVACUATION SYSTEM, Substantially Equivalent on 1989-09-28. Applicant: Laser Technologies Group, Inc.. Device class: 2.
Clearance details
- Applicant
- Laser Technologies Group, Inc.
- Product code
- Code FYD
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code FYD
view all- K240127 — PlumeSafe X5 Smoke Management System
- K233789 — 8Q10 Surclear Smoke Plume Evacuation System
- K213068 — Medline Smoke Evacuation Shroud
- K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System
- K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
Recalls naming K894038
K-number listed on FDA's recall record- Z-1924-2026 — Flamingo Funnel Small, Model Number SQ20012-01
- Z-1925-2026 — Flamingo Funnel Medium, Model Number SQ20012-02
- Z-1926-2026 — Flamingo Funnel Large, Model Number SQ20012-03
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K894038.
Data sourced from openFDA. This site is unofficial and independent of the FDA.