510(k) · Cleared
ClearedUgytex Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofradim Production · FTL Mesh, Surgical, Polymeric
Cleared on Jan 15, 2004 as substantially equivalent to K002699 (Medical Device Consultants, Inc., 2001) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1999. 70 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K991400 (1999). 3 ancestors in all. 70 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- This deviceK033376 Ugytex MeshSofradim Production · 2004
- Descendant · cites it directly · 61 of its ownK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- Descendant · 2 generations on · 31 of its ownK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
- Descendant · cites it directly · 17 of its ownK073287 Prevadh MeshSofradim Production · 2008
- Descendant · 2 generations on · 15 of its ownK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- Descendant · 2 generations on · 15 of its ownK081050 Parietex Progrip MeshSofradim Production · 2008
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K040998Modification to Parietex Composite (Pco) MeshSofradim Production · 2004 · cites it directly61descendants
- K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005 · 2 generations on31descendants
- K073287Prevadh MeshSofradim Production · 2008 · cites it directly17descendants
- K081126Parietex Composite Mono PM MeshSofradim Production · 2008 · 2 generations on15descendants
- K081050Parietex Progrip MeshSofradim Production · 2008 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| 0 (this device) | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| +1 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| +2 | K050187 | Parietex Composite Pco-OS and Pco-OB Meshes | Sofradim Production | 2005 | — |
| +1 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| +2 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| +2 | K081050 | Parietex Progrip Mesh | Sofradim Production | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K002699 | Parietex Composite (Pco) MeshSummary page 1…UGYTEX® Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh 3. PREDICATE DEVICES Sofradim Parietex® Composite Mesh K002699 Sofradim Parietene® Mesh K991400 Ethicon Gynemesh Prolene Soft K013718 4. DEVICE DES… | 2001 |
| * | K991400 | Parietene Polypropylene MeshSummary page 1…Classification Name: Surgical Mesh 3. PREDICATE DEVICES Sofradim Parietex® Composite Mesh K002699 Sofradim Parietene® Mesh K991400 Ethicon Gynemesh Prolene Soft K013718 4. DEVICE DESCRIPTION The UGYTEX Mesh is a surgical mesh used… | 1999 |
| * | K013718 | Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic…Summary page 1…DEVICES Sofradim Parietex® Composite Mesh K002699 Sofradim Parietene® Mesh K991400 Ethicon Gynemesh Prolene Soft K013718 4. DEVICE DESCRIPTION The UGYTEX Mesh is a surgical mesh used during open or laparoscopic procedures. The UGYTE… | 2002 |
What descends from it? (70)
See all 703 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The UGYTEX Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033376 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033376: Ugytex Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033376
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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