FAS
- Product code
- FAS
- Device name
- Electrode, Electrosurgical, Active, Urological
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 58 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251403 | 2025-12-05 | Dornier Medtech America Inc (Dmta) | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Med… | |
| K250522 | 2025-06-27 | Multi4 Medical AB | Multi4 System | |
| K240504 | 2024-06-12 | Lamidey Noury Medical | PLASMA EDGE System |
Official FDA classification page: FAS
Classification and pathway per current FDA publications. Data from openFDA (CC0).