ODG · Endoscopic Ultrasound System, Gastroenterology-Urology
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | ODG |
|---|---|
| Device Name | Endoscopic Ultrasound System, Gastroenterology-Urology |
| 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 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Oct 3, 2025 | SESE |
| K251542 | InstaFAN | Onepass Medical , Ltd. | Jul 18, 2025 | SESE |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | Mar 8, 2024 | SESE |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | Dec 27, 2023 | SESE |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | Dec 30, 2022 | SESE |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | Aug 19, 2022 | SESE |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | Aug 4, 2022 | SESE |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation | Jun 3, 2022 | SESE |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | Dec 6, 2021 | SESE |
| K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | Dec 30, 2020 | SESE |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | Pentax of America, Inc. | Jul 23, 2020 | SESE |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | Sep 5, 2019 | SESE |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | Aug 21, 2018 | SESE |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | Apr 19, 2018 | SESE |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. | Jan 11, 2018 | SESE |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | Oct 27, 2017 | SESE |
| K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | Sep 29, 2017 | SESE |
| K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner | Pentax of America, Inc. | Apr 13, 2017 | SESE |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | Jan 30, 2017 | SESE |
| K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | May 3, 2016 | SESE |
Top Applicants
- Pentax Precision Instrument Corp. — 7 clearances
- Pentax of America, Inc. — 6 clearances
- Fujifilm Corporation — 4 clearances
- Boston Scientific Corporation — 4 clearances
- Pentax Medical Company — 3 clearances
