FDF · Colonoscope And Accessories, Flexible/Rigid
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FDF |
|---|---|
| Device Name | Colonoscope And Accessories, Flexible/Rigid |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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 111)
Showing 20 most recent of 111 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Jan 30, 2026 | SESE |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | Sep 24, 2025 | SESE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | May 23, 2025 | SESE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | May 15, 2025 | SESE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | Jan 3, 2025 | SESE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | Oct 4, 2024 | SESE |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Feb 16, 2024 | SESE |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | Nov 3, 2023 | SESE |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | Oct 20, 2023 | SESE |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S | Sep 15, 2023 | SESE |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | Sep 8, 2023 | SESE |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | Aug 17, 2023 | SESE |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | Feb 10, 2023 | SESE |
| K213773 | Insufflation Retention Device | Bpendo, LLC | Jul 21, 2022 | SESE |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | Apr 11, 2022 | SESE |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | Apr 6, 2022 | SESE |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) | Saneso, Inc. | Apr 1, 2022 | SESE |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | Feb 10, 2022 | SESE |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | Oct 22, 2021 | SESE |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | Apr 29, 2021 | SESE |
Top Applicants
- Pentax Precision Instrument Corp. — 11 clearances
- Motus GI Medical Technologies , Ltd. — 7 clearances
- Lumendi, LLC — 6 clearances
- Avantis Medical Systems, Inc. — 6 clearances
- Smart Medical Systems , Ltd. — 5 clearances
