FDA 510(k)

Expansores de Tissue de Mama ARTOURA com Superfície Lisa

Número K: K161176 · 2016-05-23

Data da decisão2016-05-23

Código do produtoLCJ

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARTOURA Breast Tissue Expanders with Smooth Surface is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K161176. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARTOURA Breast Tissue Expanders with Smooth Surface?

ARTOURA Breast Tissue Expanders with Smooth Surface is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K161176.

When did ARTOURA Breast Tissue Expanders with Smooth Surface receive FDA 510(k) clearance?

ARTOURA Breast Tissue Expanders with Smooth Surface received FDA 510(k) clearance on 2016-05-23, under 510(k) number K161176.

Who is the listed applicant for ARTOURA Breast Tissue Expanders with Smooth Surface?

The FDA 510(k) record lists Mentor Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface?

The FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface is LCJ.

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

Outros registros que listam Mentor Worldwide, LLC como candidato(a)

K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander K241552MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander K182335CPX 4 Breast Tissue Expander with Smooth Surface

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: LCJ)

K254126Natrelle 133S Tissue ExpandersAbbVie K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC K214124Expansores Tissulares AlloX2 ProSientra, Inc.

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.