FDA 510(k)

Sonishield 100 Antimicrobial Ultrasound Gel

Numéro K : K151070 · 2016-01-13

Date de décision2016-01-13

Code produitMUI

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Sonishield 100 Antimicrobial Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Quotient Medical. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151070. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sonishield 100 Antimicrobial Ultrasound Gel?

Sonishield 100 Antimicrobial Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Quotient Medical. The 510(k) number is K151070.

When did Sonishield 100 Antimicrobial Ultrasound Gel receive FDA 510(k) clearance?

Sonishield 100 Antimicrobial Ultrasound Gel received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151070.

Who is the listed applicant for Sonishield 100 Antimicrobial Ultrasound Gel?

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

What is the FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel?

The FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel is MUI.

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 : MUI)

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

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.