FDA 510(k)

Tisuthes 电子e-PTFE 手术贴

K号: K201153 · 2023-06-13

申请人Shanghai Suokang Medical Implants Co., Ltd.

决定日期2023-06-13

产品代码OWR

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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器械摘要

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