Clearance Summary
Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance under submission number K201153, sponsored by Shanghai Suokang Medical Implants Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-06-13.
- Submission: K201153
- Applicant / Sponsor: Shanghai Suokang Medical Implants Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2023-06-13
Classification & Regulation
This clearance is catalogued under FDA product code OWR and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.