FDA 510(k)

VitaMESH Macroporous PP Surgical Mesh

Номер K: K172636 · 2018-04-30

Дата решения2018-04-30

Код продуктаFTL

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

VitaMESH Macroporous PP Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Proxy Biomedical , Ltd.. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K172636. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VitaMESH Macroporous PP Surgical Mesh?

VitaMESH Macroporous PP Surgical Mesh is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Proxy Biomedical , Ltd.. The 510(k) number is K172636.

When did VitaMESH Macroporous PP Surgical Mesh receive FDA 510(k) clearance?

VitaMESH Macroporous PP Surgical Mesh received FDA 510(k) clearance on 2018-04-30, under 510(k) number K172636.

Who is the listed applicant for VitaMESH Macroporous PP Surgical Mesh?

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

What is the FDA product code for VitaMESH Macroporous PP Surgical Mesh?

The FDA product code for VitaMESH Macroporous PP Surgical Mesh is FTL.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FTL)

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Официальный источник

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