FDA 510(k)

GERDX-System

Numéro K : K233240 · 2024-06-21

Date de décision2024-06-21

Code produitODE

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

GERDX-System is the device name listed in this FDA 510(k) record. The listed applicant is G-Surg GmbH. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233240. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the GERDX-System?

GERDX-System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is G-Surg GmbH. The 510(k) number is K233240.

When did GERDX-System receive FDA 510(k) clearance?

GERDX-System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233240.

Who is the listed applicant for GERDX-System?

The FDA 510(k) record lists G-Surg GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERDX-System?

The FDA product code for GERDX-System is ODE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : ODE)

K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.

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.