FBN — Choledochoscope And Accessories, Flexible/Rigid Class II
Classification Details
- Product Code
- FBN
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251338 | scivita medical technology co | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, | January 20, 2026 |
| K251170 | tangent endoscopy | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tange | September 12, 2025 |
| K243535 | shanghai seegen photoelectric technology co | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV | March 7, 2025 |
| K241444 | shenzhen hugemed medical technical development co | Biliary Pancreaticobiliary Scope System | January 21, 2025 |
| K233752 | centerpoint systems | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly I | May 2, 2024 |
| K231497 | shenzhen hugemed medical technical development co | Choledochoscope System | March 6, 2024 |
| K231105 | shanghai anqing medical instrument co | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | October 17, 2023 |
| K223741 | zhuhai pusen medical technology co | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Fl | June 22, 2023 |
| K222261 | shanghai seegen photoelectric technology co | Flexible Video-Choledochoscope System | April 20, 2023 |
| K221784 | micro-tech (nanjing) co | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | February 16, 2023 |
| K200483 | boston scientific corporation | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | May 21, 2020 |
| K183636 | boston scientific corporation | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Cat | January 22, 2019 |
| K181439 | boston scientific corporation | SpyGlass DS and DS II Direct Visualization System | August 23, 2018 |
| K161147 | endocure technologies | EndoCure Model EUR078A | June 7, 2016 |
| K142922 | boston scientific corporation | SpyGlass DS Direct Visualization System | January 16, 2015 |
| K113120 | olympus medical systems | CHF-Y0005 | September 25, 2012 |
| K093507 | olympus medical systems corporation | OLYMPUS CHF TYPE Y0003 | March 10, 2010 |
| K081456 | olympus medical systems corporation | OLYMPUS CHF TYPE V | November 6, 2008 |
| K082576 | olympus medical systems corporation | XCHF-T160 VIDEOSCOPE | October 21, 2008 |
| K080586 | olympus medical systems corporation | OLYMPUS XCHF TYPE B180Y1 | May 6, 2008 |