Cleared Traditional

Endoscopic Video Image Processor (RP-IPD-V1000F)

K243321 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Gastroenterology & Urology
Feb 2025
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K243321 is an FDA 510(k) clearance for the Endoscopic Video Image Processor (RP-IPD-V1000F), a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 7, 2025, 107 days after receiving the submission on October 23, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K243321 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2024
Decision Date February 07, 2025
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FET — Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.

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