FDA 510(k)

Solução AirSeal® dV - Cap de Canula AirSeal® e Conjunto de Tubo Filtado Bifurcado AirSeal®

Número K: K211104 · 2021-08-19

Data da decisão2021-08-19

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211104. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Conmed Corporation. The 510(k) number is K211104.

When did AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set receive FDA 510(k) clearance?

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211104.

Who is the listed applicant for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

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

What is the FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set?

The FDA product code for AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set is HIF.

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 Conmed Corporation como candidato(a)

K261363Y-Knotless™ Flex Anchors K253763Y-Knotless™ Flex Anchors K252946BioBrace® Extra-Articular Ligament Augmentation Kit K251530CONMED Argo Knotless® Anchor K250395BioBrace ® RC Delivery System K244025Argo Knotless GENESYS Anchor

Ver todos os 47 dispositivos →

Dispositivos Relacionados (Código: HIF)

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insuflatório (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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.