510(k) · Cleared
ClearedTisuthes e-PTFE Surgical Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Suokang Medical Implants Co., Ltd. · OWR Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
Cleared on Jun 13, 2023 as substantially equivalent to K021889 (Surgical Technology Laboratories, Inc., 2002) and 1 other predicate after a 1,139-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 13, 2023
- Review
- 1,139 days
- Class
- Class II
- Product code
- OWR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933367 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK933367 Gore-Tex Facial ImplantW. L. Gore & Associates, Inc. · 1994
- 1 generation backK091011 Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl") · 2009
- This deviceK201153 Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933367 | Gore-Tex Facial Implant | W. L. Gore & Associates, Inc. | 1994 | — |
| −1 | K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler) | Surgical Technology Laboratories, Inc ("Stl") | 2009 | — |
| 0 (this device) | K201153 | Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021889 | Surgiform Augmentation Material (S.F.a.M.)Summary page 4…rgical Patch Common Name: Surgical mesh Classification Panel: General & Plastic Surgery Product Code: FTL , OWR Device Classification: Class II 4. The Predicate Devices K021889 Trade/Device Name: Surgiform Augmentation Material K091011 Trade/Device Name: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)… | 2002 |
| * | K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Summary page 4…l: General & Plastic Surgery Product Code: FTL , OWR Device Classification: Class II 4. The Predicate Devices K021889 Trade/Device Name: Surgiform Augmentation Material K091011 Trade/Device Name: PureForm ePTFE Facial Implants (Nasal, Chin, Malar) 5. Device Description… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K021889.
How does its category compare?
All OWR devicesOWR Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWR
Too few OWR 510(k)s in any year since 2007 to give a median.
Recalls per year · OWR
No recall names OWR since 2007.
Adverse event reports per year · OWR
No MAUDE report names OWR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TisuthesTM e-PTFE Surgical Patches are indicated for facial plastic and reconstructive surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201153 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201153: Tisuthes e-PTFE Surgical Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201153
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026