# K201153: Tisuthes e-PTFE Surgical Patch

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Suokang Medical Implants Co., Ltd.
- Decided: Jun 13, 2023 after 1,139 days
- Product code: OWR (Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933367 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021889: Surgiform Augmentation Material (S.F.a.M.), Surgical Technology Laboratories, Inc. (2002) Summary page 4.
- K091011: Pureform Eptfe Facial Implants (Nasal, Chin, Maler), Surgical Technology Laboratories, Inc ("Stl") (2009) Summary page 4.

## Indications for use
TisuthesTM e-PTFE Surgical Patches are indicated for facial plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K201153
Methodology: https://510kreport.com/methodology