LGZ
- Product code
- LGZ
- Device name
- Warmer, Thermal, Infusion Fluid
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 75 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260988 | 2026-04-24 | Mequ A/S | °M Warmer System with °M Station | |
| K252636 | 2025-11-18 | The Surgical Company International B.V… | Fluido Compact System | |
| K251733 | 2025-09-04 | The Surgical Company International BV … | Fluido® AirGuard System | |
| K232107 | 2024-05-31 | Mequ A/S | °M Warmer System |
Official FDA classification page: LGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).