Cleared Traditional

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

K241500 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Gastroenterology & Urology

Jul 2024

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K241500 is an FDA 510(k) clearance for the Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS), a Cystoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAJ), submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 12, 2024, 45 days after receiving the submission on May 28, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K241500 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2024
Decision Date	July 12, 2024
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FAJ — Cystoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine And Perform Procedures Within The Urinary Tract. 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).