FDS · Gastroscope And Accessories, Flexible/Rigid
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FDS |
|---|---|
| Device Name | Gastroscope 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 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | Feb 17, 2026 | SESE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | Feb 6, 2026 | SESE |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax of America, Inc. | Dec 16, 2025 | SESE |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | Oct 31, 2025 | SESE |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Oct 10, 2025 | SESE |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | Jun 27, 2025 | SESE |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Jun 16, 2025 | SESE |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | Jun 10, 2025 | SESE |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | May 30, 2025 | SESE |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | May 1, 2025 | SESE |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. | Dec 6, 2024 | SESE |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | Oct 11, 2024 | SESE |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | Sep 4, 2024 | SESE |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | Jun 19, 2024 | SESE |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 | Ambu A/S | Apr 5, 2024 | SESE |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited | Nov 17, 2023 | SESE |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | Sep 1, 2023 | SESE |
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | Jan 27, 2023 | SESE |
| K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Feb 14, 2022 | SESE |
| K212382 | Ambu® aScope Gastro, Ambu® aBox2 | Ambu A/S | Feb 3, 2022 | SESE |
Top Applicants
- Fujifilm Corporation — 15 clearances
- Pentax Precision Instrument Corp. — 7 clearances
- Pentax of America, Inc. — 5 clearances
- Fujinon, Inc. — 5 clearances
- Olympus Optical Co., Ltd. — 3 clearances
