FDA 510(k)

Défendo Fujifilm 500/600 Vanne à air/eau à usage unique, Défendo Fujifilm 500/600 Vanne de suction à usage unique, Défendo Fujifilm 500/600 Vanne de biopsie à usage unique, Endogator Fujifilm 500/600 Connecteur à usage unique

Numéro K : K232067 · 2024-03-22

DemandeurMedivators (A Subsidiary of Steris Corporation)

Date de décision2024-03-22

Code produitODC

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.

DécisionÉquivalence substantielle

Résumé du dispositif

Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector is the device name listed in this FDA 510(k) record. The listed applicant is Medivators (A Subsidiary of Steris Corporation). It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K232067. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Medivators (A Subsidiary of Steris Corporation). The 510(k) number is K232067.

When did Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector receive FDA 510(k) clearance?

Who is the listed applicant for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

The FDA 510(k) record lists Medivators (A Subsidiary of Steris Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

The FDA product code for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector is ODC.

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Autres dossiers indiquant Medivators (A Subsidiary of Steris Corporation) en tant que demandeur

K232004Valve de biopsie à usage unique Pentax Defendo, Vanne à air/eau à usage unique Pentax Defendo, Vanne de suction à usage unique Pentax Defendo, Connecteur à usage unique Pentax Endogator K232329Défendo Fujifilm 700 Vanne de Biopsie à Usage Unique; Défendo Fujifilm 700 Vanne Air/Eau à Usage Unique; Défendo Fujifilm 700 Vanne de Suction à Usage Unique; ENDOGATOR Fujifilm 700 Connecteur à Usage Unique; Défendo Fujifilm 700 Adaptateur de Nettoyage à Usage Unique

Dispositifs connexes (Code : ODC)

K252933DYNE PORTDyne Medical Group, Inc.K250145Adaptateur de Port de BiopsieEndosound, Inc.K252910Orca Air/Eau et Vannes de SuctionBoston Scientific K250949Vanne à Succion (MAJ-1443); Vanne Air/Eau (MAJ-1444)Olympus Medical Systems Corporation K250732Kit de valve d'endoscopie à usage uniqueYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Source officielle

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