FDA Product Code
FDA Product Code FBN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-03 | Traditional | PDF ↗ |
| K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | 2026-03-19 | Traditional | PDF ↗ |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. | 2026-01-20 | Traditional | PDF ↗ |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | 2025-09-12 | Traditional | PDF ↗ |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025-03-07 | Special | PDF ↗ |
| K241444 | Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-01-21 | Traditional | PDF ↗ |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | CenterPoint Systems, LLC | 2024-05-02 | Traditional | PDF ↗ |
| K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023-10-17 | Traditional | PDF ↗ |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. | 2023-06-22 | Traditional | PDF ↗ |
| K222261 | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-04-20 | Traditional | PDF ↗ |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020-05-21 | Traditional | PDF ↗ |
| K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | Boston Scientific Corporation | 2019-01-22 | Special | PDF ↗ |
| K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018-08-23 | Special | PDF ↗ |
| K161147 | EndoCure Model EUR078A | Endocure Technologies, Inc. | 2016-06-07 | Traditional | PDF ↗ |
| K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015-01-16 | Traditional | PDF ↗ |
| K113120 | CHF-Y0005 | Olympus Medical Systems Corp. | 2012-09-25 | Traditional | PDF ↗ |
| K093507 | OLYMPUS CHF TYPE Y0003 | Olympus Medical Systems Corporation | 2010-03-10 | Traditional | PDF ↗ |
| K081456 | OLYMPUS CHF TYPE V | Olympus Medical Systems Corporation | 2008-11-06 | Traditional | PDF ↗ |
| K082576 | XCHF-T160 VIDEOSCOPE | Olympus Medical Systems Corporation | 2008-10-21 | Traditional | PDF ↗ |
| K080586 | OLYMPUS XCHF TYPE B180Y1 | Olympus Medical Systems Corporation | 2008-05-06 | Traditional | PDF ↗ |
| K060269 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM | Acmi Corporation | 2006-03-31 | Traditional | PDF ↗ |
| K051886 | OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F | Olympus Medical Systems Corporation | 2005-11-14 | Traditional | PDF ↗ |
| K972926 | MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K971977 | KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K962172 | FLEXIBLE MINI-FIBERSCOPES | Richard Wolf Medical Instruments Corp. | 1996-12-02 | Traditional | PDF ↗ |
| K944473 | XCHF-33 CHOLEDOCHOFIBERSCOPE | Olympus America, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K953286 | FCP-9P, FIBER CHOLEDOCHOSCOPE | Pentax Precision Instrument Corp. | 1995-11-03 | Traditional | PDF ↗ |
| K951191 | FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | Traditional | PDF ↗ |
| K942112 | KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE | Karl Storz Endoscopy | 1995-02-28 | Traditional | PDF ↗ |
| K933906 | CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION | Fujinon, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K935834 | TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE | Technology Marketing Group | 1994-03-07 | Traditional | PDF ↗ |
| K931382 | 11274 AC FLEXINBLE CHOLEDOCHOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1993-06-18 | Traditional | PDF ↗ |
| K924228 | OMEGASCOPE | Omega Universal Technologies, Ltd. | 1993-02-26 | Traditional | PDF ↗ |
| K920224 | DOSCOPE AND ACESSORIES | Applied Laparoscopy | 1992-08-21 | Traditional | PDF ↗ |
| K915681 | CHOLEDOCHOSCOPE | Applied Laparoscopy | 1992-01-30 | Traditional | PDF ↗ |
| K912120 | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE | Olympus Corp. | 1991-08-07 | Traditional | PDF ↗ |
| K911480 | FLEXIBLE CHOLEDOCHOSCOPE | United States Endoscopy Group, Inc. | 1991-06-20 | Traditional | PDF ↗ |
| K904799 | CHF-B20 CHOLEDOCHOSCOPE | Olympus Corp. | 1991-03-27 | Traditional | PDF ↗ |
| K901010 | FLEXIBLE CHOLEDOCHOSCOPE | Intramed Laboratories, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K821974 | PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A | Pentax Precision Instrument Corp. | 1982-08-10 | Traditional | PDF ↗ |
| K771367 | CHOLEDOCHOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-08-02 | Traditional | PDF ↗ |
Product code FBN · Class II · Gastroenterology, Urology. Data: openFDA.