Scivita Medical Technology Co., Ltd. · Class II · Cleared Jan 20, 2026
| K-number | K251338 |
| Device name | 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) |
| Applicant | Scivita Medical Technology Co., Ltd. |
| Product code | FBN |
| Device class | Class II |
| Decision date | Jan 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Cholangioscope Visualization System comprises a single-use Video Cholangioscope and a Full HD Visualization Endoscopic Image Processor. The cholangioscope provides diagnostic and therapeutic imaging of the pancreatico-biliary system and offers a working channel for other endoscopic accessories. The image processor connects to the electronic endoscope and displays images on its LCD display and/or external monitor.
The subject cholangioscope uses CMOS image sensors, two LED illumination modules, one working channel for accessories, two irrigation channels, and four-direction bending control via wheel. The key difference from the predicate is the lighting method: the subject uses internal LED while the predicate uses external LED for illumination. Minor differences exist in dimensions, weight, optical specifications (depth of field, bending angle), and working channel length, but these do not raise safety or effectiveness concerns.
Electrical safety and electromagnetic compatibility per IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-2-18:2009, and IEC 60601-1-2:2014+A1:2020. Photobiological safety per IEC 62471:2006. Optical performance per ISO 8600-1:2015, ISO 8600-3:2019, and ISO 8600-4:2014. Mechanical testing, shelf life validation per ASTM F1980-21, package validation per ASTM D4169-22, and ERCP model simulation testing.
The subject device and predicate SpyScope DS II Access and Delivery Catheter share similar technological characteristics including CMOS sensors, LED lighting modules, working channel for accessories, and irrigation channels with four-direction bending. The indications for use are identical—both support diagnostic and therapeutic pancreatico-biliary procedures. Minor differences in lighting method, dimensions, and optical specifications do not raise different questions of safety and effectiveness. Non-clinical testing demonstrates the subject device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov