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FBN · Choledochoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology · 13 clearances · 10 unique sponsors

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Device class

Class II

Regulation 876.1500

Total clearances

13

2020-05-21 → 2026-04-03

Last 12 months

4

Unique sponsors

10

Definition

What is Choledochoscope And Accessories, Flexible/Rigid

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).

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

GU

Regulation number

876.1500

Implant

N

Life-sustain / support

N

GMP exempt

N

Third-party review

N

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen HugeMed Medical Technical Development Co., Ltd.	2	0	2025-01-21
Shanghai SeeGen Photoelectric Technology Co., Ltd.	2	0	2025-03-07
Mirco-Tech (Nanjing) Co., Ltd.	2	2	2026-04-03
Shanghai AnQing Medical Instrument Co., Ltd.	1	0	2023-10-17
Micro-Tech (Nanjing) Co., Ltd.	1	0	2023-02-16
Tangent Endoscopy, LLC	1	1	2025-09-12
CenterPoint Systems, LLC	1	0	2024-05-02
Zhuhai Pusen Medical Technology Co., Ltd.	1	0	2023-06-22
Scivita Medical Technology Co., Ltd.	1	1	2026-01-20
Boston Scientific Corporation	1	0	2020-05-21

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
47550	CPT	—	High	CPT code for choledochoscopy with diagnostic/therapeutic procedures

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-03	K254153	Mirco-Tech (Nanjing) Co., Ltd.	Single-use Video Scope; PB Digital Controller
2026-03-19	K253139	Mirco-Tech (Nanjing) Co., Ltd.	Disposable Distal Cap
2026-01-20	K251338	Scivita Medical Technology Co., Ltd.	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)
2025-09-12	K251170	Tangent Endoscopy, LLC	Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
2025-03-07	K243535	Shanghai SeeGen Photoelectric Technology Co., Ltd.	Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
2025-01-21	K241444	Shenzhen HugeMed Medical Technical Development Co., Ltd.	Biliary Pancreaticobiliary Scope System
2024-05-02	K233752	CenterPoint Systems, LLC	Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
2024-03-06	K231497	Shenzhen HugeMed Medical Technical Development Co., Ltd.	Choledochoscope System
2023-10-17	K231105	Shanghai AnQing Medical Instrument Co., Ltd.	Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
2023-06-22	K223741	Zhuhai Pusen Medical Technology Co., Ltd.	Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
2023-04-20	K222261	Shanghai SeeGen Photoelectric Technology Co., Ltd.	Flexible Video-Choledochoscope System
2023-02-16	K221784	Micro-Tech (Nanjing) Co., Ltd.	Single-use Video Pancreaticobiliary Scope, PB Digital Controller
2020-05-21	K200483	Boston Scientific Corporation	SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller