510(k) · Cleared
ClearedSil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced Radiopaque Sheeting, Extra Firm Gra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technical Products, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 1, 1997 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 1, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Sil-Tec Medical Grade Silicone Sheeting is suitable for external use or short-term implantation (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practitioner, for his/her own custom patient-specific applications. Patient selection and suitability is up to the surgeon/medical practitioner user. The surgeon/medical practitioner user must rely on his or her own best medical judgment and…
Read the full statement (200 words)
Sil-Tec Medical Grade Silicone Sheeting is suitable for external use or short-term implantation (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practitioner, for his/her own custom patient-specific applications. Patient selection and suitability is up to the surgeon/medical practitioner user. The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device.
The following are some indications where silicone sheeting has been successfully employed: Surgical repairs; anchoring device for hemodialysis shunts; temporary covering for a prenatally ruptured omphalocele during staged repair; surgical repair of urethral strictures; protective sheathing to help facilitate neural regeneration and tendon healing; surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus (Warning Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular joint applications); other surgical procedures; and as insulating material for tissue accumulation.
It is the surgeon/medical practitioner user's responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the product's performance in a specific application.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971472: Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced Radiopaque Sheeting, Extra Firm Gra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026