FBN
- Product code
- FBN
- Device name
- Choledochoscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 43 (all years; only the last 3 years are listed here)
FDA classification definition
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254153 | 2026-04-03 | Mirco-Tech (Nanjing) Co., Ltd. | Single-use Video Scope; PB Digital Controller | |
| K253139 | 2026-03-19 | Mirco-Tech (Nanjing) Co., Ltd. | Disposable Distal Cap | |
| K251338 | 2026-01-20 | Scivita Medical Technology Co., Ltd. | Cholangioscope Visualization System (Single-use Vide… | |
| K251170 | 2025-09-12 | Tangent Endoscopy, LLC | Tangent Single-Use Digital System: Tangent Single-Us… | |
| K243535 | 2025-03-07 | Shanghai SeeGen Photoelectric Technolo… | Flexible Video-Choledochoscope (CHV-110J-U); Flexibl… | |
| K241444 | 2025-01-21 | Shenzhen HugeMed Medical Technical Dev… | Biliary Pancreaticobiliary Scope System | |
| K233752 | 2024-05-02 | CenterPoint Systems, LLC | Dragonfly Pancreaticobiliary Scope; Dragonfly Digi… | |
| K231497 | 2024-03-06 | Shenzhen HugeMed Medical Technical Dev… | Choledochoscope System | |
| K231105 | 2023-10-17 | Shanghai AnQing Medical Instrument Co.… | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-2… |
Official FDA classification page: FBN
Classification and pathway per current FDA publications. Data from openFDA (CC0).