KOE
- Product code
- KOE
- Device name
- Dilator, Urethral
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5520
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 27 (all years; only the last 3 years are listed here)
Official FDA classification page: KOE
Classification and pathway per current FDA publications. Data from openFDA (CC0).