FDA 510(k)

Ancora de Sutura Sem Nó Apollo

Número K: K230123 · 2023-05-03

Data da decisão2023-05-03

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apollo Knotless Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Maruho Medical. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K230123. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Apollo Knotless Suture Anchor?

Apollo Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-05-03. The listed applicant is Maruho Medical. The 510(k) number is K230123.

When did Apollo Knotless Suture Anchor receive FDA 510(k) clearance?

Apollo Knotless Suture Anchor received FDA 510(k) clearance on 2023-05-03, under 510(k) number K230123.

Who is the listed applicant for Apollo Knotless Suture Anchor?

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

What is the FDA product code for Apollo Knotless Suture Anchor?

The FDA product code for Apollo Knotless Suture Anchor is MBI.

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: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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.