FBO
- Product code
- FBO
- Device name
- Cystourethroscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- 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)
- 19 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K244001 | 2025-05-02 | Karl Storz SE & CO. KG | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL | |
| K243409 | 2024-11-27 | Karl Storz SE & CO. KG | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274 |
Official FDA classification page: FBO
Classification and pathway per current FDA publications. Data from openFDA (CC0).