510(k) · Cleared
ClearedSilgel Topical Gel Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nagor, Ltd. · MDA Elastomer, Silicone, For Scar Management
Cleared on Mar 30, 1998 as substantially equivalent to K894226 (Dow Corning Wright, 1990) after a 145-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 30, 1998
- Review
- 145 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894226 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK894226 Silastic Soft SheetingDow Corning Wright · 1990
- This deviceK974172 Silgel Topical Gel SheetNagor, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894226 | Silastic Soft Sheeting | Dow Corning Wright | 1990 | — |
| 0 (this device) | K974172 | Silgel Topical Gel Sheet | Nagor, Ltd. | 1998 | — |
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 MDA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K894226 | Silastic Soft SheetingSummary page 1…d . Predicate Devices The predicate devices are all silicone topical gel sheets and include: Spenco Silicone Gelsheet, a pre-enactment device Silastic Soft Sheeting, (K894226) [January 3, 1990] Epi-Derm Silicone Gel Sheeting, [510(k) number unknown] New Beginnings Topical Gel Sheeting, [510(k) number… | 1990 |
| * | — | Spenco Silicone Gelsheet Named without a submission number | |
| * | — | Epi-Derm Silicone Gel Sheeting Named without a submission number | |
| * | — | New Beginnings Topical Gel Sheeting Named without a submission number | |
| * | — | DermaSof Gel Sheeting Named without a submission number | |
| * | — | Cica-Care Adhesive Gel Sheet Named without a submission number |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K894226.
How does its category compare?
All MDA devicesMDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDA
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MDA
Too few MDA 510(k)s in any year since 2007 to give a median.
Recalls per year · MDA
No recall names MDA since 2007.
Adverse event reports per year · MDA
3in 2025
MAUDE reports naming product code MDA, 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 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars.
Silgel helps relieve friction on newly healed scars when used as a splint lining insert.
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/K974172 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974172: Silgel Topical Gel Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974172
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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