Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more— 510(k) K251338

Clearance details

Device name as filed

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

Code FBN

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2025-04-30

Decision date

2026-01-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suzhou, CN

• K254153 — Single-use Video Scope; PB Digital Controller2026-04-03
• K253139 — Disposable Distal Cap2026-03-19
• K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller2025-09-12
• K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)2025-03-07
• K241444 — Biliary Pancreaticobiliary Scope System2025-01-21

• K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)2026-08-14
• K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more2025-03-27
• K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more2025-03-19
• K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)2024-10-23
• K240192 — Single-use Extraction Baskets2024-10-15

Death

8

Malfunction

951

Total

959

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →