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)
FDA 510(k) K251338 · Scivita Medical Technology Co., Ltd.
510(k) numberK251338
Submission
- 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.
Suzhou, CN - Received
- April 30, 2025
- Decision date
- January 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBN – Choledochoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254153 | Single-use Video Scope; PB Digital ControllerFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/03/2026SE |
| K253139 | Disposable Distal CapFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 03/19/2026SE |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent…FBN · Traditional | Tangent Endoscopy, LLC | 09/12/2025SE |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBN · Special | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 03/07/2025SE |
| K241444 | Biliary Pancreaticobiliary Scope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 01/21/2025SE |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly…FBN · Traditional | CenterPoint Systems, LLC | 05/02/2024SE |
| K231497 | Choledochoscope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 03/06/2024SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 10/17/2023SE |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…FBN · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 06/22/2023SE |
| K222261 | Flexible Video-Choledochoscope SystemFBN · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 04/20/2023SE |
More from Shanghai SeeGen Photoelectric Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | 08/14/2026SE |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…FGB · Traditional | 03/27/2025SE |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…EOQ · Special | 03/19/2025SE |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)EOQ · Traditional | 10/23/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | 10/15/2024SE |
| K231521 | Broncho Videoscope SystemEOQ · Traditional | 11/14/2023SE |
| K222812 | InsufflatorHIF · Traditional | 05/16/2023SE |
| K221252 | Scivita 4KINSIGHT ICG Imaging SystemGCJ · Traditional | 01/13/2023SE |
| K210379 | Broncho Videoscope SystemEOQ · Traditional | 07/28/2021SE |
| K203255 | 4K UHD LaparoscopeGCJ · Traditional | 02/24/2021SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K251338) received a 510(k) decision of Substantially Equivalent on January 20, 2026, 265 days after the submission was received.
What is the product code of K251338?
The FDA product code is FBN – Choledochoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.