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FDA 510(k)

EndoVive Kit de placement initial à un seul clic avec profil bas et connecteur ENFit, Kit de tube gastrostomique de remplacement EndoVive à profil bas avec connecteur ENFit, Ensemble de nutrition par angle droit EndoVive avec connecteur ENFit, Ensemble de nutrition par bolus EndoVive avec connecteur ENFit, Tube de décompression EndoVive avec connecteur ENFit

Numéro K : K161003 · 2016-06-17

DemandeurBoston Scientific Corporation
Date de décision2016-06-17
Code produitPIF
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.
DécisionUnknown

Résumé du dispositif

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K161003. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Questions fréquentes

What is the EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K161003.

When did EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector receive FDA 510(k) clearance?

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector received FDA 510(k) clearance on 2016-06-17, under 510(k) number K161003.

Who is the listed applicant for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

L'enregistrement 510(k) de la FDA liste la Boston Scientific Corporation comme demandeur. Cela ne constitue pas en soi l'établissement du fabricant du dispositif.

What is the FDA product code for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

The FDA product code for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is PIF.

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Autres dossiers indiquant Boston Scientific Corporation en tant que demandeur

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.

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Dispositifs connexes (Code : PIF)

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.

K260110danumed Extension Set pour bouton gastrostomiqueDanumed Medizintechnik GmbHK253715Édi Cathéter ENFit 6Fr/48 cm (6893166); Édi Cathéter ENFit 6Fr/49 cm (6893273); Édi Cathéter ENFit 6Fr/50 cm (6893274); Édi Cathéter ENFit 8Fr/50 cm (6893275); Édi Cathéter ENFit 8Fr/100 cm (6893276); Édi Cathéter ENFit 8Fr/125 cm (6893277); Édi Cathéter ENFit 12Fr/125 cm (6893278); Édi Cathéter ENFit 16Fr/125 cm (6893279)Maquet Critical Care ABK254170Kit de gastrostomie endoscopique percutanée (PEG)Degania Silicone , Ltd.K242917Système d'évacuation entérique, Sonde de médicaments entériqueHMC Premedical S.p.A.K250481Kit d'alimentation prolongé avec connecteurs ENFit™SKY Medical, a.s.K240052Ensembles de nutrition entérale à usage uniqueBeijing L&Z Medical Technology Development Co., Ltd.

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