K201153 is an FDA 510(k) clearance for the Tisuthes e-PTFE Surgical Patch. This device is classified as a Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery (Class II - Special Controls, product code OWR).
Submitted by Shanghai Suokang Medical Implants Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 13, 2023, 1139 days after receiving the submission on April 30, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Facial Plastic Surgery..
| 510(k) Number | K201153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2020 |
| Decision Date | June 13, 2023 |
| Days to Decision | 1139 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWR - Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Facial Plastic Surgery. |