FDA 510(k)

Système de livraison masculin du système d'urodynamique Glean (GUS-1000-M); Système de livraison féminin du système d'urodynamique Glean (GUS-1000-F); Urofluximètre du système d'urodynamique Glean (UFM-1000 (Urofluximètre))

Numéro K : K243052 · 2025-03-24

Date de décision2025-03-24

Code produitEXQ

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

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is the device name listed in this FDA 510(k) record. The listed applicant is Bright Uro, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243052. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Bright Uro, Inc.. The 510(k) number is K243052.

When did Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) receive FDA 510(k) clearance?

Who is the listed applicant for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

The FDA 510(k) record lists Bright Uro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

The FDA product code for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is EXQ.

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Autres dossiers indiquant Bright Uro, Inc. en tant que demandeur

K253537Système de livraison mâle du Système d'urodynamique Glean (GUS-1000-M); Système de livraison féminin du Système d'urodynamique Glean (GUS-1000-F); Mètre urinaire du Système d'urodynamique Glean (UFM-1000 (Mètre urinaire)); Capteur abdominal du Système d'urodynamique Glean (GUS-1000-A)

Dispositifs connexes (Code : EXQ)

Source officielle

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