FDA 510(k)

Tisuthes e-PTFE Surgical Patch

Номер K: K201153 · 2023-06-13

ЗаявительShanghai Suokang Medical Implants Co., Ltd.

Дата решения2023-06-13

Код продуктаOWR

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Tisuthes e-PTFE Surgical Patch is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K201153. The device is classified under product code OWR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Tisuthes e-PTFE Surgical Patch?

Tisuthes e-PTFE Surgical Patch is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. The 510(k) number is K201153.

When did Tisuthes e-PTFE Surgical Patch receive FDA 510(k) clearance?

Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance on 2023-06-13, under 510(k) number K201153.

Who is the listed applicant for Tisuthes e-PTFE Surgical Patch?

The FDA 510(k) record lists Shanghai Suokang Medical Implants Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tisuthes e-PTFE Surgical Patch?

The FDA product code for Tisuthes e-PTFE Surgical Patch is OWR.

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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