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) → FDX — Endoscopic Cytology Brush # FDX · Endoscopic Cytology Brush _Gastroenterology, Urology · 21 CFR 876.1500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX ## Overview - **Product Code:** FDX - **Device Name:** Endoscopic Cytology Brush - **Regulation:** [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **3rd-party reviewable:** yes ## 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 44) Showing 20 most recent of 44 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250993](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K250993.md) | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | Dec 18, 2025 | SESE | | [K220063](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K220063.md) | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Jul 28, 2022 | SESE | | [K192908](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K192908.md) | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | Nov 14, 2019 | SESE | | [K191485](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K191485.md) | Deflectable Brush Biopsy Set | Cook Incorporated | Jun 26, 2019 | SESE | | [K182231](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K182231.md) | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | May 1, 2019 | SESE | | [K181317](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K181317.md) | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | Feb 8, 2019 | SESE | | [K172663](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K172663.md) | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | Mar 5, 2018 | SESE | | [K171573](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K171573.md) | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | Dec 29, 2017 | SESE | | [K171607](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K171607.md) | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | Jul 31, 2017 | SESE | | [K151889](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K151889.md) | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | Jul 30, 2015 | SESE | | [K103437](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K103437.md) | US ENDOSCOPY CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | Dec 23, 2010 | SESE | | [K052279](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K052279.md) | COOK IRELAND ECHOBRUSH | Cook Ireland, Ltd. | Oct 11, 2005 | SESE | | [K040324](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K040324.md) | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | Wilson-Cook Medical, Inc. | May 20, 2004 | SESE | | [K021998](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K021998.md) | HORIZONS CYTOLOGY BRUSH | Horizons Intl. Corp. | Jul 12, 2002 | SESE | | [K965037](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K965037.md) | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | Jan 8, 1997 | SESE | | [K960004](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K960004.md) | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | Mar 20, 1996 | SESE | | [K954121](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K954121.md) | CYTOLOGY BRUSH | Lighthouse Medical, Inc. | Oct 7, 1995 | SESE | | [K944614](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K944614.md) | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | Biosearch Medical Products, Inc. | Apr 5, 1995 | SESE | | [K942144](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K942144.md) | URETHRA-BRUSH | Rovers Diagnostic Devices | Jun 27, 1994 | SESE | | [K930348](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX/K930348.md) | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | Boston Scientific Corp | Sep 3, 1993 | SESE | ## Top Applicants - Wilson-Cook Medical, Inc. — 5 clearances - United States Endoscopy Group, Inc. — 4 clearances - Telemed Systems, Inc. — 2 clearances - Medical Device Technologies, Inc. — 2 clearances - Hobbs Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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