FDA 510(k)

Endo Motor

Numéro K : K222548 · 2023-04-26

DemandeurShenzhen Perfect Medical Instruments Co., Ltd.

Date de décision2023-04-26

Code produitEKX

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Endo Motor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Perfect Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K222548. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Endo Motor?

Endo Motor is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Shenzhen Perfect Medical Instruments Co., Ltd.. The 510(k) number is K222548.

When did Endo Motor receive FDA 510(k) clearance?

Endo Motor received FDA 510(k) clearance on 2023-04-26, under 510(k) number K222548.

Who is the listed applicant for Endo Motor?

The FDA 510(k) record lists Shenzhen Perfect Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endo Motor?

The FDA product code for Endo Motor is EKX.

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 : EKX)

K261987Reusable SmartPegOsstell AB K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis 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.