FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
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)
K Number: K251338
·
Decision Jan 20, 2026
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
42
Applicant Total
12
Review Days
265
Basic Information
- 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)
- K Number
- K251338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scivita Medical Technology Co., Ltd.
- Date Received
- April 30, 2025
- Decision Date
- January 20, 2026
- Product Code
- FBN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Scivita Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Mar 27, 2025 | Substantially Equivalent |
| 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); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Mar 19, 2025 | Substantially Equivalent |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Oct 23, 2024 | Substantially Equivalent |
| K240192 | Single-use Extraction Baskets | Oct 15, 2024 | Substantially Equivalent |
| K231521 | Broncho Videoscope System | Nov 14, 2023 | Substantially Equivalent |
| K222812 | Insufflator | May 16, 2023 | Substantially Equivalent |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | Jan 13, 2023 | Substantially Equivalent |
| K210379 | Broncho Videoscope System | Jul 28, 2021 | Substantially Equivalent |
| K203255 | 4K UHD Laparoscope | Feb 24, 2021 | Substantially Equivalent |
| K200216 | 4K UHD Camera System | Aug 21, 2020 | Substantially Equivalent |