510(k) · Cleared
ClearedGore Drapeable ST/LT Regenerative Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Dec 19, 2001 after a 71-day review. The FDA summary names its predicate without a number. 144 later devices descend from it.
- Decided
- Dec 19, 2001
- Review
- 71 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
144 later devices descend from it, 2 citing it directly.
- This deviceK013346 Gore Drapeable ST/LT Regenerative MembraneW. L. Gore & Associates, Inc. · 2001
- Descendant · cites it directly · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 2 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 2 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- Descendant · 3 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- Descendant · 3 generations on · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
Showing 5 of 144 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 144 · See all- K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · cites it directly143descendants
- K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on102descendants
- K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 2 generations on77descendants
- K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 3 generations on69descendants
- K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013346 | Gore Drapeable ST/LT Regenerative Membrane | W. L. Gore & Associates, Inc. | 2001 | — |
| +1 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +2 | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| +3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| +3 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | GORE RESOLUT XT Regenerative Membrane Named without a submission number | |
| * | — | GORE OSSEOQUEST Regenerative Membranes Named without a submission number |
What descends from it? (144)
See all 1442 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?
- Of its descendants, K030782 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 143 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, implantable materials intended to aid in the healing of periodontal and bone defects. They may also be used as a membrane for bone graft containment. When used over a bone graft, GORE DRAPEABLE ST and LT Regenerative Membranes provide a stable barrier to prevent migration of bone graft material and provides a favorable environment for bone regeneration. When used in the treatment of non-spacemaking defects, GORE DRAPEABLE ST and LT Regenerative Membranes may be used in combination with spacemaking bone graft materials (e.g., autogenous bone, bone substitutes).
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/K013346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013346: Gore Drapeable ST/LT Regenerative Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013346
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026