FIE
- Product code
- FIE
- Device name
- Needle, Fistula
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 80 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253469 | 2026-08-06 | Mozarc Medical Us, LLC | Ritus Safety Fistula Cannula with Anti-Reflux Valve… | |
| K251877 | 2025-08-15 | JMS North America Corporation | JMS CAVEO A.V. Fistula Needle Set |
Official FDA classification page: FIE
Classification and pathway per current FDA publications. Data from openFDA (CC0).