510(k) · Cleared
ClearedSurgiseal Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adhezion Biomedical · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Dec 19, 2008 after a 73-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Dec 19, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 7 citing it directly.
- This deviceK082993 Surgiseal Topical Skin AdhesiveAdhezion Biomedical · 2008
- Descendant · cites it directly · 3 of its ownK130329 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
- Descendant · cites it directly · 3 of its ownK130474 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
- Descendant · cites it directly · 3 of its ownK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK123936 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly3descendants
- K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly3descendants
- K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly3descendants
- K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · 2 generations on2descendants
- K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082993 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical | 2008 | — |
| +1 | K130329 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical, LLC | 2013 | — |
| +1 | K130474 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical, LLC | 2013 | — |
| +1 | K123133 | Barle Tissue Adhesive | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | — |
| +2 | K132243 | Barle Tissue Adhesive 2 | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | 1 |
| +1 | K123936 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 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 MPN? 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 MPN device
- #1 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Dermabond High Viscosity Topical Skin Adhesive Named without a submission number |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130329 | Surgiseal Topical Skin Adhesive | 2013 | 3 |
| K130474 | Surgiseal Topical Skin Adhesive | 2013 | 3 |
| K123133 | Barle Tissue Adhesive | 2013 | 3 |
| K123936 | Surgiseal Topical Skin Adhesive | 2013 | 2 |
| K140517 | Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive | 2014 | 1 |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist… | 2016 | 0 |
| K141215 | Surgiseal Twist Topical Skin Adhesive | 2014 | 0 |
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, K130329 (Adhezion Biomedical, LLC, 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MPN devicesMPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MPN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPN
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPN
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPN
244in 2025
MAUDE reports naming product code MPN, 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 | 1 | — | 0 | 56 |
| 2008 | 1 | — | 0 | 32 |
| 2009 | 1 | — | 0 | 22 |
| 2010 | 3 | 77 | 0 | 21 |
| 2011 | 2 | — | 0 | 93 |
| 2012 | 2 | — | 0 | 135 |
| 2013 | 6 | 193 | 0 | 177 |
| 2014 | 4 | 96 | 0 | 199 |
| 2015 | 4 | 141 | 0 | 179 |
| 2016 | 5 | 173 | 0 | 194 |
| 2017 | 0 | — | 0 | 182 |
| 2018 | 0 | — | 0 | 272 |
| 2019 | 0 | — | 0 | 427 |
| 2020 | 2 | — | 0 | 225 |
| 2021 | 1 | — | 1 | 141 |
| 2022 | 0 | — | 0 | 165 |
| 2023 | 0 | — | 0 | 130 |
| 2024 | 3 | 266 | 0 | 236 |
| 2025 | 2 | — | 0 | 244 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SurgiSeal TM Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.
SurgiSeal I M Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082993: Surgiseal Topical Skin Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082993
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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