510(k) K251338 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
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., Suzhou, CN |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251338
No recall in the FDA data names this 510(k).
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