InstaFAN
FDA 510(k) K251542 · Onepass Medical , Ltd.
510(k) numberK251542
Submission
- Device name
- InstaFAN
- Applicant
- Onepass Medical , Ltd.
Katzrin, IL - Received
- May 20, 2025
- Decision date
- July 18, 2025
- 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).
Other 510(k)s with product code ODG
| 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 |
| 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 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic…ODG · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/06/2021SE |
Questions and answers
When was InstaFAN cleared by the FDA?
InstaFAN (K251542) received a 510(k) decision of Substantially Equivalent on July 18, 2025, 59 days after the submission was received.
What is the product code of K251542?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.