FDA 510(k)

Vertos mild Device Kit (MDK-0002)

Número K: K233800 · 2024-05-06

Data da decisão2024-05-06

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vertos mild Device Kit (MDK-0002) is the device name listed in this FDA 510(k) record. The listed applicant is Vertos Medical, Inc.. It received FDA 510(k) clearance on 2024-05-06 under 510(k) number K233800. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vertos mild Device Kit (MDK-0002)?

Vertos mild Device Kit (MDK-0002) is a medical device that received FDA 510(k) clearance on 2024-05-06. The listed applicant is Vertos Medical, Inc.. The 510(k) number is K233800.

When did Vertos mild Device Kit (MDK-0002) receive FDA 510(k) clearance?

Vertos mild Device Kit (MDK-0002) received FDA 510(k) clearance on 2024-05-06, under 510(k) number K233800.

Who is the listed applicant for Vertos mild Device Kit (MDK-0002)?

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

What is the FDA product code for Vertos mild Device Kit (MDK-0002)?

The FDA product code for Vertos mild Device Kit (MDK-0002) is HRX.

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: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.