FDA 510(k)

GYN-Pump PH304

Número K: K173489 · 2018-03-28

Data da decisão2018-03-28

Código do produtoHIG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

GYN-Pump PH304 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K173489. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GYN-Pump PH304?

GYN-Pump PH304 is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K173489.

When did GYN-Pump PH304 receive FDA 510(k) clearance?

GYN-Pump PH304 received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173489.

Who is the listed applicant for GYN-Pump PH304?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYN-Pump PH304?

The FDA product code for GYN-Pump PH304 is HIG.

Outros registros que listam W.O.M. World of Medicine GmbH como candidato(a)

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.

K250795PUREVUE™ FMS K201361PNEUMOCLEAR K173311ARTHRO-Pump PA304 K172040Sistema de Controle de Fluxo Aquilex AQL-100S K170784PNEUMOCLEAR K163320LAP-Pump PP110

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: HIG)

K261706Endomat Select (UP220)KARL STORZ SE & CO. KG K251273Asurys Fluid Management SystemBoston Scientific Corporation K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLC K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG K180735Endomat SelectKarl Storz SE & CO. KG

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.