EG-3830UT, Video Ultrasound Gastroscope
FDA 510(k) K031789 · Pentax Precision Instrument Corp.
510(k) numberK031789
Submission
- Device name
- EG-3830UT, Video Ultrasound Gastroscope
- Applicant
- Pentax Precision Instrument Corp.
Orangeburg, NY, US - Received
- June 10, 2003
- Decision date
- August 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODG – Endoscopic Ultrasound System, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 07/31/2026SE |
| K260428 | RIVOS EUS Access Device (M00553900)ODG · Traditional | Boston Scientific Corporation | 06/17/2026SE |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 10/03/2025SE |
| K251542 | InstaFANODG · Traditional | Onepass Medical , Ltd. | 07/18/2025SE |
| K231813 | Ultrasonic GastrovideoscopeODG · Traditional | Sonoscape Medical Corp. | 03/08/2024SE |
| K232518 | EndoSound Vision System; EVSODG · Traditional | Endosound, Inc. | 12/27/2023SE |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODG · Special | Boston Scientific Corporation | 12/30/2022SE |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UTODG · Traditional | Fujifilm Corporation | 08/19/2022SE |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580URODG · Special | Fujifilm Corporation | 08/04/2022SE |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG · Traditional | Fujifilm Corporation | 06/03/2022SE |
More from Fujifilm Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
| K964815 | AP-4000, Air Pulse Sensory StimulatorLLN · Traditional | 09/04/1997SE |
Questions and answers
When was EG-3830UT, Video Ultrasound Gastroscope cleared by the FDA?
EG-3830UT, Video Ultrasound Gastroscope (K031789) received a 510(k) decision of Substantially Equivalent on August 8, 2003, 59 days after the submission was received.
What is the product code of K031789?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.