510(k) K201153
K201153 is an FDA 510(k) premarket notification submitted by Shanghai Suokang Medical Implants Co., Ltd. for the device "Tisuthes e-PTFE Surgical Patch". The FDA issued a decision of Substantially Equivalent on June 13, 2023. The device falls under product code OWR (Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2023
- Date Received
- April 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists in facial plastic surgery.