K251542
- 510(k) number
- K251542
- Device name
- InstaFAN
- Applicant
- Onepass Medical , Ltd. IL
- Product code
- ODG — Endoscopic Ultrasound System, Gastroenterology-Urolo
- Decision date
- 2025-07-18
- Date received
- 2025-05-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K251542.pdf
Official FDA record: K251542
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.