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510(k) Data Aggregation

K Number

Device Name

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

Manufacturer

Tangent Endoscopy LLC

Date Cleared

2025-09-12

(150 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology-Urology (GU)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

Tangent Endoscopy LLC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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