Tisuthes
Tisuthes e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery. The filing lists sheet, block and preformed three-dimensional forms, including chin, nasal,…
Tisuthes e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery. The filing lists sheet, block and preformed three-dimensional forms, including chin, nasal, temporal, piriform and malar shapes.
The supplied model list includes patch and implant codes such as TPS02, TPR02, TPN17 and TPC09. These codes identify different listed configurations rather than one uniform shape.
Material and Format
The e-PTFE patch is supplied sterile in multiple sizes. Separate model tables describe sheet, block and preformed implant configurations, including chin, nasal, temporal, piriform and malar forms.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Shanghai Suokang Medical Implants Co., Ltd., China |
|---|---|
| FDA product code | OWR |
| Device type | Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| 510(k) | K201153 |
| Record published | 2026-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TPR02 | In distribution | |
| TPN17 | In distribution | |
| TPT04 | In distribution | |
| TPR08 | In distribution | |
| TPR01 | In distribution | |
| TPN22 | In distribution | |
| TPN12 | In distribution | |
| TPS02 | In distribution | |
| TPN16 | In distribution | |
| TPC09 | In distribution | |
| TPC10 | In distribution | |
| TPS10 | In distribution | |
| TPS12 | In distribution | |
| TPN05 | In distribution | |
| TPC01 | In distribution | |
| TPN02 | In distribution | |
| TPF01 | In distribution | |
| TPF02 | In distribution | |
| TPS03 | In distribution | |
| TPS07 | In distribution | |
| TPC13 | In distribution | |
| TPN14 | In distribution | |
| TPC15 | In distribution | |
| TPR09 | In distribution | |
| TPN19 | In distribution | |
| TPC08 | In distribution | |
| TPN07 | In distribution | |
| TPN06 | In distribution | |
| TPC07 | In distribution | |
| TPR07 | In distribution | |
| TPC04 | In distribution | |
| TPN23 | In distribution | |
| TPN04 | In distribution | |
| TPN13 | In distribution | |
| TPS09 | In distribution | |
| TPN20 | In distribution | |
| TPS06 | In distribution | |
| TPC03 | In distribution | |
| TPN21 | In distribution | |
| TPN03 | In distribution | |
| TPR03 | In distribution | |
| TPM01 | In distribution | |
| TPC05 | In distribution | |
| TPN09 | In distribution | |
| TPS04 | In distribution | |
| TPT01 | In distribution | |
| TPT02 | In distribution | |
| TPN10 | In distribution | |
| TPC02 | In distribution | |
| TPF03 | In distribution | |
| TPN11 | In distribution | |
| TPS08 | In distribution | |
| TPT03 | In distribution | |
| TPR06 | In distribution | |
| TPR05 | In distribution | |
| TPS01 | In distribution | |
| TPC06 | In distribution | |
| TPR04 | In distribution | |
| TPC11 | In distribution | |
| TPC14 | In distribution | |
| TPF04 | In distribution | |
| TPN08 | In distribution | |
| TPS11 | In distribution | |
| TPC16 | In distribution | |
| TPC12 | In distribution | |
| TPM02 | In distribution | |
| TPS05 | In distribution | |
| TPN15 | In distribution | |
| TPN18 | In distribution | |
| TPC17 | In distribution | |
| TPN01 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201153 | 2023-06-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.