FCX
- Product code
- FCX
- Device name
- Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 25
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262152 | 2026-07-24 | VISION MEDICAL Co., Ltd. | VS-370CF, VS-370CT | |
| K240847 | 2024-10-30 | Ide Vision, Ltd. | MedicCO2LON (MedicCO2LON) |
Official FDA classification page: FCX
Classification and pathway per current FDA publications. Data from openFDA (CC0).