Ultrasonic Gastrovideoscope
FDA 510(k) K231813 · Sonoscape Medical Corp.
510(k) numberK231813
Submission
- Device name
- Ultrasonic Gastrovideoscope
- Applicant
- Sonoscape Medical Corp.
Shenzhen, CN - Received
- June 21, 2023
- Decision date
- March 8, 2024
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic…ODG · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/06/2021SE |
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| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…IYN · Traditional | 05/15/2026SE |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…IYN · Traditional | 12/05/2025SE |
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| K222596 | S90 Exp Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 02/10/2023SE |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 09/15/2022SE |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 09/13/2022SE |
| K222020 | HD-550 Video Endoscope SystemNWB · Traditional | 09/08/2022SE |
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| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 07/30/2020SE |
Questions and answers
When was Ultrasonic Gastrovideoscope cleared by the FDA?
Ultrasonic Gastrovideoscope (K231813) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 261 days after the submission was received.
What is the product code of K231813?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.