510(k) · Cleared
ClearedSURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adhezion Biomedical, LLC · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Nov 8, 2016 as substantially equivalent to K082993 (Adhezion Biomedical, 2008) after a 211-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Nov 8, 2016
- Review
- 211 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082993 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK082993 Surgiseal Topical Skin AdhesiveAdhezion Biomedical · 2008
- This deviceK161011 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin…Adhezion Biomedical, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082993 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical | 2008 | — |
| 0 (this device) | K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive… | Adhezion Biomedical, LLC | 2016 | — |
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 |
|---|---|---|---|
| * | K082993 | Surgiseal Topical Skin AdhesiveSummary page 4…nd Plastic Surgery Devices Regulation Class II, under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SURGISEAL® Topical Skin Adhesive - K082993 device(s) to which equivalence is claimed Reason for 510(k) Labeling change submission Device Description SURGISEA… | 2008 |
| † | K123936 | Surgiseal Topical Skin Adhesive | 2013 |
| † | K130329 | Surgiseal Topical Skin Adhesive | 2013 |
| † | K140517 | Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive | 2014 |
| † | K130474 | Surgiseal Topical Skin Adhesive | 2013 |
| † | K133963 | Surgiseal Twist (TM) Topical Skin Adhesive | 2014 |
| † | K141215 | Surgiseal Twist Topical Skin Adhesive | 2014 |
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.
- 6 other devices also cite its predicate K082993.
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. 2016, 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 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 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/K161011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161011: SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist 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/K161011
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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