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510(k) K251170

Device
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
Applicant
Tangent Endoscopy, LLC
510(k) number
K251170
Product code
FBN
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-12
Date received
2025-04-15
Regulation
876.1500
Classification name
Choledochoscope And Accessories, Flexible/Rigid
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
Daniel Amendola
Address
2140 Dupont Hwy. Camden DE US 19934 19934

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FBN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation2018-08-23
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