510(k) · Cleared
ClearedPhasix ST Parastomal Hernia Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol, Inc., A Subsidiary of C.R. Bard, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Sep 28, 2026 as substantially equivalent to K162934 (Cook Biotech Incorporated, 2017) after a 143-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Sep 28, 2026
- Review
- 143 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921895 (1992). 14 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 1 generation backK162934 Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated · 2017
- This deviceK261543 Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −1 | K162934 | Biodesign Parastomal Hernia Repair Graft | Cook Biotech Incorporated | 2017 | — |
| 0 (this device) | K261543 | Phasix ST Parastomal Hernia Mesh | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 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 OWT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWT device
- #1 K243241 Phasix ST Umbilical Hernia Patchscore 10.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K162934 | Biodesign Parastomal Hernia Repair GraftSummary page 5…uct Codes: OWT, OOD, FTL Predicate Device: Name of Device: BioDesign® Parastomal Hernia Repair Graft (K162934) Common or Usual Name: Surgical Mesh Classification Name: Mesh, Surgical Regulatory Class:… | 2017 |
| † | K143380 | Phasix ST Mesh | 2015 |
| † | K161092 | GalaSHAPE 3D | 2016 |
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 34 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All OWT devicesOWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OWT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWT
Too few OWT 510(k)s in any year since 2007 to give a median.
Recalls per year · OWT
No recall names OWT since 2007.
Adverse event reports per year · OWT
82in 2025
MAUDE reports naming product code OWT, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 31 |
| 2019 | 2 | — | 0 | 61 |
| 2020 | 1 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 76 |
| 2024 | 1 | — | 0 | 65 |
| 2025 | 1 | — | 0 | 82 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Phasix™ ST Parastomal Hernia Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures for the repair of parastomal hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261543: Phasix ST Parastomal Hernia Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261543
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026