PLUME-AWAY SMOKE EVACUATION SYSTEM
FDA 510(k) clearance K894038 · decided 1989-09-28
Clearance details
- K-number
- K894038
- Device name
- PLUME-AWAY SMOKE EVACUATION SYSTEM
- Applicant
- Laser Technologies Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-06
- Decision date
- 1989-09-28
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flamingo Funnel Small, Model Number SQ20012-01 recall (Z-1924-2026) | SurgiSmoke Solutions | 2026-04-22 |
| Flamingo Funnel Medium, Model Number SQ20012-02 recall (Z-1925-2026) | SurgiSmoke Solutions | 2026-04-22 |
| Flamingo Funnel Large, Model Number SQ20012-03 recall (Z-1926-2026) | SurgiSmoke Solutions | 2026-04-22 |