Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) → FBN — Choledochoscope And Accessories, Flexible/Rigid # FBN · Choledochoscope And Accessories, Flexible/Rigid _Gastroenterology, Urology · 21 CFR 876.1500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN ## Overview - **Product Code:** FBN - **Device Name:** Choledochoscope And Accessories, Flexible/Rigid - **Regulation:** [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Classification Rationale (1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Recent Cleared Devices (20 of 43) Showing 20 most recent of 43 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254153](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K254153.md) | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | Apr 3, 2026 | SESE | | [K253139](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K253139.md) | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | Mar 19, 2026 | SESE | | [K251338](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K251338.md) | 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) | Scivita Medical Technology Co., Ltd. | Jan 20, 2026 | SESE | | [K251170](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K251170.md) | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | Sep 12, 2025 | SESE | | [K243535](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K243535.md) | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Mar 7, 2025 | SESE | | [K241444](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K241444.md) | Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Jan 21, 2025 | SESE | | [K233752](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K233752.md) | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps | CenterPoint Systems, LLC | May 2, 2024 | SESE | | [K231497](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K231497.md) | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Mar 6, 2024 | SESE | | [K231105](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K231105.md) | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | Oct 17, 2023 | SESE | | [K223741](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K223741.md) | 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) | Zhuhai Pusen Medical Technology Co., Ltd. | Jun 22, 2023 | SESE | | [K222261](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K222261.md) | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Apr 20, 2023 | SESE | | [K221784](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K221784.md) | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | Feb 16, 2023 | SESE | | [K200483](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K200483.md) | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | May 21, 2020 | SESE | | [K183636](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K183636.md) | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | Boston Scientific Corporation | Jan 22, 2019 | SESE | | [K181439](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K181439.md) | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | Aug 23, 2018 | SESE | | [K161147](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K161147.md) | EndoCure Model EUR078A | Endocure Technologies, Inc. | Jun 7, 2016 | SESE | | [K142922](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K142922.md) | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | Jan 16, 2015 | SESE | | [K113120](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K113120.md) | CHF-Y0005 | Olympus Medical Systems Corp. | Sep 25, 2012 | SESE | | [K093507](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K093507.md) | OLYMPUS CHF TYPE Y0003 | Olympus Medical Systems Corporation | Mar 10, 2010 | SESE | | [K081456](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN/K081456.md) | OLYMPUS CHF TYPE V | Olympus Medical Systems Corporation | Nov 6, 2008 | SESE | ## Top Applicants - Olympus Medical Systems Corporation — 5 clearances - Boston Scientific Corporation — 4 clearances - KARL STORZ Endoscopy-America, Inc. — 3 clearances - Pentax Precision Instrument Corp. — 3 clearances - Applied Laparoscopy — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FBN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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