FDA 510(k)

Natrelle 133S Tissue Expanders

Número K: K254126 · 2026-01-16

RequerenteAbbVie

Data da decisão2026-01-16

Código do produtoLCJ

DecisãoSubstantially Equivalent

Resumo do dispositivo

Natrelle 133S Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is AbbVie. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K254126. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Natrelle 133S Tissue Expanders?

Natrelle 133S Tissue Expanders is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is AbbVie. The 510(k) number is K254126.

When did Natrelle 133S Tissue Expanders receive FDA 510(k) clearance?

Natrelle 133S Tissue Expanders received FDA 510(k) clearance on 2026-01-16, under 510(k) number K254126.

Who is the listed applicant for Natrelle 133S Tissue Expanders?

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

What is the FDA product code for Natrelle 133S Tissue Expanders?

The FDA product code for Natrelle 133S Tissue Expanders 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

Dispositivos Relacionados (Código: LCJ)

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.K221127Sientra, inc. PortfinderSientra, 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.