FBN — Choledochoscope And Accessories, Flexible/Rigid Class II
FDA product code FBN covers "Choledochoscope And Accessories, Flexible/Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K254153 | mirco-tech (nanjing) co | Single-use Video Scope; PB Digital Controller | April 3, 2026 |
| K253139 | mirco-tech (nanjing) co | Disposable Distal Cap | March 19, 2026 |
| 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 |