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510(k) Data Aggregation

K Number

Device Name

Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

Manufacturer

Guangzhou Red Pine Medical Instrument Co.,Ltd.

Date Cleared

2024-06-21

(105 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

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Device Name :

Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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