FDA 510(k)

GFS - Sterile Screws and Top Hat

Número K: K253858 · 2026-08-05

RequerenteT.A.G. Medical Products Corporation, Ltd.

Data da decisão2026-08-05

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GFS - Sterile Screws and Top Hat is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K253858. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GFS - Sterile Screws and Top Hat?

GFS - Sterile Screws and Top Hat is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K253858.

When did GFS - Sterile Screws and Top Hat receive FDA 510(k) clearance?

GFS - Sterile Screws and Top Hat received FDA 510(k) clearance on 2026-08-05, under 510(k) number K253858.

Who is the listed applicant for GFS - Sterile Screws and Top Hat?

The FDA 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GFS - Sterile Screws and Top Hat?

The FDA product code for GFS - Sterile Screws and Top Hat is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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