FDA.reportPublic FDA data

510(k) K251542

Device
InstaFAN
Applicant
Onepass Medical , Ltd.
510(k) number
K251542
Product code
ODG
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-18
Date received
2025-05-20
Regulation
876.1500
Classification name
Endoscopic Ultrasound System, Gastroenterology-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jacob Ben Arie
Address
1st The Four St. Katzrin Industrial Park Katzrin IL 1290000 1290000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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