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FDA 510(k)

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)

Número K: K232951 · 2023-10-20

RequerenteSteris
Data da decisão2023-10-20
Código do produtoODC
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232951. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)?

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Steris. The 510(k) number is K232951.

When did BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) receive FDA 510(k) clearance?

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232951.

Who is the listed applicant for BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)?

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

What is the FDA product code for BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)?

The FDA product code for BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) is ODC.

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Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Fonte oficial

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