510(k) · Cleared
ClearedGore Bioabsorbable Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Dec 31, 2003 as substantially equivalent to K030782 (W. L. Gore & Associates, Inc., 2003) and 4 other predicates after a 37-day review. Its family tree reaches back 6 generations to 1985. 39 later devices descend from it.
- Decided
- Dec 31, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K842066 (1985). 38 ancestors in all, the oldest K810428 (1981). 39 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 3 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 2 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 1 generation backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- This deviceK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK071016 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007 · cites it directly13descendants
- K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009 · cites it directly12descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 3 generations on11descendants
- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −5 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −3 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −2 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −1 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| +1 | K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +3 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 2…TMC) copolymer fiber. This is the same material used in the predicate device (GORE DRAPEABLE ST Regenerative Membrane, K013346, cleared December 19, 2001 and SEAMGUARD, K030782 cleared April 21, 2003). As packaged, the GORE BIOABSORBABLE MESH is a tailorable, bioabsorbable material intended to be a tempo… | 2003 |
| * | K013346 | Gore Drapeable ST/LT Regenerative MembraneSummary page 2…olide: 33% trimethylene carbonate by weight) (PGA: TMC) copolymer fiber. This is the same material used in the predicate device (GORE DRAPEABLE ST Regenerative Membrane, K013346, cleared December 19, 2001 and SEAMGUARD, K030782 cleared April 21, 2003). As packaged, the GORE BIOABSORBABLE MESH is a tailora… | 2001 |
| * | K810428 | VicrylSummary page 3…, Flagstaff, AZ) — K030782 » GORE DRAPEABLE ST Regenerative Membrane (W.L. Gore & Associates, Inc., Flagstaff, AZ) —- K013346 * Vicryl (Ethicon Inc., Somerville, NJ) — K810428 DePuy Restore® Orthobiologic Soft Tissue Implant (DePuy, Inc., Warsaw, IN) - K001738 » FortaGen (Organogenesis Inc., Canton, M… | 1981 |
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 3…ciates, Inc., Flagstaff, AZ) —- K013346 * Vicryl (Ethicon Inc., Somerville, NJ) — K810428 DePuy Restore® Orthobiologic Soft Tissue Implant (DePuy, Inc., Warsaw, IN) - K001738 » FortaGen (Organogenesis Inc., Canton, MA) — K021105 Summary of Studies W. L. Gore & Associates, Inc. performed device integr… | 2000 |
| * | K021105 | Fortaflex Surgical MeshSummary page 3…con Inc., Somerville, NJ) — K810428 DePuy Restore® Orthobiologic Soft Tissue Implant (DePuy, Inc., Warsaw, IN) - K001738 » FortaGen (Organogenesis Inc., Canton, MA) — K021105 Summary of Studies W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE BIOABSORBABLE MESH… | 2002 |
What descends from it? (39)
See all 397 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K071016 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K030782.
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.
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?
The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to:
Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular).
Muscle flap reinforcement
Perforated tissue repair
General tissue reconstruction’s (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)
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/K033671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033671: Gore Bioabsorbable Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033671
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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