FDA 510(k)

Memodyn Staple

Número K: K161587 · 2017-02-01

RequerenteAustin & Associates, Inc./Telos Medical Equipment

Data da decisão2017-02-01

Código do produtoJDR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Memodyn Staple is the device name listed in this FDA 510(k) record. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K161587. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Memodyn Staple?

Memodyn Staple is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. The 510(k) number is K161587.

When did Memodyn Staple receive FDA 510(k) clearance?

Memodyn Staple received FDA 510(k) clearance on 2017-02-01, under 510(k) number K161587.

Who is the listed applicant for Memodyn Staple?

The FDA 510(k) record lists Austin & Associates, Inc./Telos Medical Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Memodyn Staple?

The FDA product code for Memodyn Staple is JDR.

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: JDR)

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax Surgical K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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.