FDA 510(k)

HumaPen Savvio

Número K: K160668 · 2016-06-03

Data da decisão2016-06-03

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HumaPen Savvio is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160668. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HumaPen Savvio?

HumaPen Savvio is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Eli Lilly and Company, Inc.. The 510(k) number is K160668.

When did HumaPen Savvio receive FDA 510(k) clearance?

HumaPen Savvio received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160668.

Who is the listed applicant for HumaPen Savvio?

The FDA 510(k) record lists Eli Lilly and Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HumaPen Savvio?

The FDA product code for HumaPen Savvio is FMF.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.