FDA 510(k)

Processeur d'Images Vidéo Endoscopique (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Endoscope Vidéo à Usage Unique (RP-GI-G02A, RP-GI-G02B), Endoscope Vidéo Colique à Usage Unique (RP-GI-C02A, RP-GI-C02B)

Numéro K : K232043 · 2024-02-16

DemandeurGuangzhou Red Pine Medical Instrument Co., Ltd.

Date de décision2024-02-16

Code produitFDF

Comité consultatifPolitique : medical-regulatory-v1. GUIDELINES FOR MEDICAL DEVICE REGULATION 1. Introduction 1.1 This document outlines the regulatory requirements for medical devices as established by the U.S. Food and Drug Administration (FDA). 1.2 These guidelines are intended to assist companies in understanding and complying with the applicable regulations for the marketing and sale of medical devices in the United States. 2. Classification of Medical Devices 2.1 Medical devices are classified into three classes (I, II, and III) based on the risk they pose to the user. 2.2 Class I devices are considered lowest risk and typically require a 510(k) submission to the FDA. 2.3 Class II devices are considered moderate risk and may require a Pre-Market Approval (PMA) or a 510(k) submission. 2.4 Class III devices are considered highest risk and generally require a PMA submission. 3. 510(k) Submission 3.1 A 510(k) submission is a pre-market notification submitted to the FDA to demonstrate that a new medical device is substantially equivalent to an existing device that is legally marketed in the United States. 3.2 The 510(k) submission must include a detailed description of the device, its intended use, and the data to support its safety and effectiveness. 4. Pre-Market Approval (PMA) 4.1 A Pre-Market Approval (PMA) is a submission required for certain high-risk medical devices. 4.2 The PMA submission must include extensive clinical data, including the results of clinical trials, to demonstrate the safety and effectiveness of the device. 5. Investigational Device Exemptions (IDE) 5.1 An Investigational Device Exemption (IDE) is a regulatory pathway that allows for the investigation of a new medical device in clinical studies. 5.2 An IDE submission must include a detailed description of the device, the study protocol, and the rationale for the investigation. 6. Good Manufacturing Practices (GMP) 6.1 Good Manufacturing Practices (GMP) are regulations that ensure the quality of medical devices. 6.2 Companies must comply with GMP requirements to ensure that their devices are safe and effective. 7. Labeling and Advertising 7.1 Labeling and advertising of medical devices must comply with FDA regulations. 7.2 Companies must ensure that their labeling and advertising are accurate, clear, and not misleading. 8. Post-Market Surveillance 8.1 Post-market surveillance is a process used to monitor the safety and effectiveness of medical devices after they have been marketed. 8.2 Companies are required to report any adverse events or changes in the device's performance to the FDA. 9. Conclusion 9.1 These guidelines provide a comprehensive overview of the regulatory requirements for medical devices in the United States. 9.2 Companies are encouraged to consult with the FDA or a regulatory expert to ensure compliance with all applicable regulations.

DécisionSubstantially Equivalent

Résumé du dispositif

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) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K232043. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is 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)?

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) is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K232043.

When did 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) receive FDA 510(k) clearance?

Who is the listed applicant for 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)?

The FDA 510(k) record lists Guangzhou Red Pine Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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)?

The FDA product code for 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) is FDF.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549Étude pilote de phase 1 sur la sécurité du FLASHNOT_YET_RECRUITING NCT06562205Systèmes PAP Études Cliniques Externes (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

Autres dossiers indiquant Guangzhou Red Pine Medical Instrument Co., Ltd. en tant que demandeur

K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)K243321Processeur d'Images Vidéos Endoscopiques (RP-IPD-V1000F)K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)K241500Processeur d'Images Vidéo Endoscopique (RP-IPD-V2000EF) ; Cysto-Nephroscope Vidéo Flexible à Usage Unique (RP-U-C01F, RP-U-C01FS)

Voir tous les 10 dispositifs →

Dispositifs connexes (Code : FDF)

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Appareil de Rétention d'Insufflation (IRD) (11173-325-101)BPEndo, LLC K260423Attachements distaux endoscopiques jetablesYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Tunique amovible pour extrémité distaleShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.