510(k) · Cleared
ClearedSurgical Fabrics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FTL Mesh, Surgical, Polymeric
Cleared on Nov 15, 1996 after an 88-day review. The FDA summary names its predicate without a number. 280 later devices descend from it.
- Decided
- Nov 15, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
280 later devices descend from it, 2 citing it directly.
- This deviceK963226 Surgical FabricsBoston Scientific Corp · 1996
- Descendant · cites it directly · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
- Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 115 of its ownK972651 IN-SlingInfluence, Inc. · 1997
- Descendant · 2 generations on · 114 of its ownK980482 Triangle SlingInfluence, Inc. · 1998
- Descendant · 3 generations on · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 280 · See all- K992159Surgisis SlingCook Biotech, Inc. · 1999 · cites it directly204descendants
- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
- K972651IN-SlingInfluence, Inc. · 1997 · cites it directly115descendants
- K980482Triangle SlingInfluence, Inc. · 1998 · 2 generations on114descendants
- K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · 3 generations on113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963226 | Surgical Fabrics | Boston Scientific Corp | 1996 | — |
| +1 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| +2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| +2 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| +3 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 13 | 0 |
| 2007 | 9 | 0 |
| 2008 | 20 | 0 |
| 2009 | 20 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 19 | 0 |
| 2013 | 15 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 14 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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? (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 |
|---|---|---|---|
| * | — | Trelex Natural® Mesh Named without a submission number | |
| * | — | Supple Peri-Guard® Named without a submission number | |
| * | — | Gore-Tex® Soft Tissue Patch Named without a submission number | |
| * | — | Marlex® Mesh Named without a submission number | |
| * | — | Mersilene® Mesh Named without a submission number |
What descends from it? (280)
See all 2802 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, K992159 (Cook Biotech, Inc., 1999) has gone furthest, with 204 descendants of its own.
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 proposed Surgical Fabrics are implants which are intended to reinforce soft tissue where weakness exists for the urological, gynecological and gastroenterological anatomy inclusive but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair. colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, and sacro-colposuspension.
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/K963226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963226: Surgical Fabrics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963226
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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