Cleared Traditional

Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

K232043 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Gastroenterology & Urology

Feb 2024

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K232043 is an FDA 510(k) clearance for the Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B), a Colonoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDF), submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 16, 2024, 221 days after receiving the submission on July 10, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K232043 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2023
Decision Date	February 16, 2024
Days to Decision	221 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FDF — Colonoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).