FDA 510(k)

Système de biopsie Mammotome elite - Problème 13G, Système de biopsie Mammotome elite - Problème 10G, Système de biopsie Mammotome elite - Porte-outil, Système de biopsie Mammotome elite - Stylet d'introduit 13G, Système de biopsie Mammotome elite - Stylet d'introduit 10G

Numéro K : K153709 · 2016-08-08

Date de décision2016-08-08

Code produitKNW

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

Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K153709. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet?

Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K153709.

When did Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet receive FDA 510(k) clearance?

Who is the listed applicant for Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet?

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

What is the FDA product code for Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet?

The FDA product code for Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet is KNW.

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Autres dossiers indiquant Devicor Medical Products, Inc. en tant que demandeur

K260365Système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, Module de contrôle; Sonde à usage unique du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, 8 gauge; Ensemble de cible à usage unique du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, 8 gauge; Pied-poussoir du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double; Plateau réutilisable du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double; Batterie du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double K253761HydroMARK™ Plus Marqueur de Site de Biopsie du sein (Forme Dragonfly); HydroMARK™ Plus Marqueur de Site de Biopsie du sein (Forme Colibri)K243095Système de biopsie par insertion unique AutoCore™ Mammotome K240527HydroMARK™ Plus Marqueur de Site de Biopsie du sein (Forme d'Oiseau Mouchette) (4010-02-15-T6)K232615LumiMARK™ Marqueur de Site de Biopsie (LM0215T (Forme Tulipe)); LumiMARK™ Marqueur de Site de Biopsie (LM0215L (Forme Lotus)); LumiMARK™ Marqueur de Site de Biopsie (LM0215R (Forme Rose))K221961HydroMARK Plus Marque de Site de Biopsie du sein

Voir tous les 14 dispositifs →

Dispositifs connexes (Code : KNW)

K260517Instrument de biopsie de noyau automatiqueZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Système de Biopsie mammaire et d'Extraction de TissuBard Peripheral Vascular, Inc.K262792Système de biopsie Brevera avec technologie d'imagerie CorLumina (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Aiguilles de Biopsie AutomatiquesPromisemed Hangzhou Meditech Co., Ltd.K260365Système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, Module de contrôle; Sonde à usage unique du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, 8 gauge; Ensemble de cible à usage unique du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double, 8 gauge; Pied-poussoir du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double; Plateau réutilisable du système de biopsie mammaire assistée par vide Mammotome Prima™ MR Double; Batterie du système de biopsie mammaire assistée par vide Mammotome Prima™ MR DoubleDevicor Medical Products, Inc.

Source officielle

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