FDA 510(k)

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle

Numéro K : K221308 · 2022-10-17

DemandeurJiangxi Maidikang Medical Devices Co., Ltd.

Date de décision2022-10-17

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221308. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. The 510(k) number is K221308.

When did Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle receive FDA 510(k) clearance?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221308.

Who is the listed applicant for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

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

What is the FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

The FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is FMF.

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 : FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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.