Tisuthes e-PTFE Surgical Patch— 510(k) K201153

Name: FDA 510(k) clearance K201153
Creator: U.S. Food and Drug Administration
Published: 2023-06-13

Substantially Equivalent

Shanghai Suokang Medical Implants Co., Ltd.

FDA 510(k) clearance K201153 for Tisuthes e-PTFE Surgical Patch, Substantially Equivalent on 2023-06-13. Applicant: Shanghai Suokang Medical Implants Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Suokang Medical Implants Co., Ltd.
Product code: Code OWR
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2020-04-30
Decision date: 2023-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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