510(k) Report

510(k) · Cleared

Cleared

Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive

K140517510(k) TraditionalCleared Apr 28, 201459-day reviewClass II21 CFR 878.4010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Adhezion Biomedical, LLC · MPN Tissue Adhesive For The Topical Approximation Of Skin

Cleared on Apr 28, 2014 as substantially equivalent to K082993 (Adhezion Biomedical, 2008) and 6 other predicates after a 59-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.

Decided
Apr 28, 2014
Review
59 days
Class
Class II
Product code
MPN
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to P010002 (2002). 12 ancestors in all, the oldest P960052 (1998). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 3 other ancestors2008: 1 other ancestor1998: 1 other ancestor2010: 2 other ancestors2014: 1 descendant clearedP010002 · Indermil (TM) Tissue Adhesive · Covidien Lp, Formerly Registered AS United States · 2002K083531 · Liquiband Ultima, Model LB0004 · Medlogic Global, Ltd. · 2009K100284 · Liquiband Ultima, Lut 003 · Medlogic Global Limited · 2010K110184 · Liquiband Flow Control · Medlogic Global Limited · 2011K122446 · Liquidband Flow Control · Advanced Medical Solutions (Plymouth), Ltd. · 2012 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K122446 · Liquidband Flow Control · Advanced Medical Solutions (Plymouth), Ltd. · 2012 · recalledK110184 · Liquiband Flow Control · Medlogic Global Limited · 2011K100284 · Liquiband Ultima, Lut 003 · Medlogic Global Limited · 2010K083531 · Liquiband Ultima, Model LB0004 · Medlogic Global, Ltd. · 2009P010002 · Indermil (TM) Tissue Adhesive · Covidien Lp, Formerly Registered AS United States · 2002−50
  1. Root · 5 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
  2. 4 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
  3. 3 generations backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
  4. 2 generations backK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
  5. 1 generation backK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · Recalled
  6. This deviceK140517 Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
  7. Descendant · cites it directly · 0 of its ownK141215 Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5P010002Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States2002—
−4K083531Liquiband Ultima, Model LB0004Medlogic Global, Ltd.2009—
−3K100284Liquiband Ultima, Lut 003Medlogic Global Limited2010—
−2K110184Liquiband Flow ControlMedlogic Global Limited2011—
−1K122446Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd.20121
0 (this device)K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC2014—
+1K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200810
201020
201330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K140517, 2002–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082993Surgiseal Topical Skin Adhesive
Summary page 1
…gulation Class 11,under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SUROISEAL~' Topical Skin Adhesive (K082993, K 123936, K 130329) device(s) to which SURGISEAL StylusTM Topical Skin Adhesive (K1 30474) equivalence is…
Adhezion Biomedical2008—
*K123936Surgiseal Topical Skin Adhesive
Summary page 1
…Class 11,under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SUROISEAL~' Topical Skin Adhesive (K082993, K 123936, K 130329) device(s) to which SURGISEAL StylusTM Topical Skin Adhesive (K1 30474) equivalence is…
Adhezion Biomedical, LLC2013—
*K130329Surgiseal Topical Skin Adhesive
Summary page 1
…Class 11,under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SUROISEAL~' Topical Skin Adhesive (K082993, K 123936, K 130329) device(s) to which SURGISEAL StylusTM Topical Skin Adhesive (K1 30474) equivalence is Dermabon…
Adhezion Biomedical, LLC2013—
*K130474Surgiseal Topical Skin Adhesive
Summary page 1
…lly Marketed SUROISEAL~' Topical Skin Adhesive (K082993, K 123936, K 130329) device(s) to which SURGISEAL StylusTM Topical Skin Adhesive (K1 30474) equivalence is Dermabond® Topical Skin Adhesive (P960052/S003) claimed lnde…
Adhezion Biomedical, LLC2013—
*P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)
Summary page 1
…3936, K 130329) device(s) to which SURGISEAL StylusTM Topical Skin Adhesive (K1 30474) equivalence is Dermabond® Topical Skin Adhesive (P960052/S003) claimed lndermil Tm Tissue Adhesive (PO010002/S004) Liqu…
Closure Medical Corp.19982
*P010002Indermil (TM) Tissue Adhesive
Summary page 1
…ive (K1 30474) equivalence is Dermabond® Topical Skin Adhesive (P960052/S003) claimed lndermil Tm Tissue Adhesive (PO010002/S004) Liquil~and® Flow Control (K 122446) Reason for 510(k) Labeling Change to i…
Covidien Lp, Formerly Registered AS United States2002—
*K122446Liquidband Flow Control
Summary page 1
…Adhesive (P960052/S003) claimed lndermil Tm Tissue Adhesive (PO010002/S004) Liquil~and® Flow Control (K 122446) Reason for 510(k) Labeling Change to include Microbial Barrier description submission Device Description…
Advanced Medical Solutions (Plymouth), Ltd.20121

Also cleared against K082993: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC20140

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?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 3 of the 12 ancestors have a recall of any class.
  • Of its descendants, K141215 (Adhezion Biomedical, LLC, 2014) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K082993.

How does its category compare?

All MPN devices

MPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MPN

2in 2025

2007: 12008: 12009: 12010: 32011: 22012: 22013: 62014: 42015: 42016: 52020: 22021: 12024: 32025: 2
2007high 6 (2013) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPN

266in 2024

2010: 77 days median2013: 193 days median2014: 96 days median2015: 141 days median2016: 173 days median2024: 266 days median
2007high 266 (2024) · low 77 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MPN

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MPN

244in 2025

2007: 562008: 322009: 222010: 212011: 932012: 1352013: 1772014: 1992015: 1792016: 1942017: 1822018: 2722019: 4272020: 2252021: 1412022: 1652023: 1302024: 2362025: 244
2007high 427 (2019) · low 21 (2010)2025

MAUDE reports naming product code MPN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—056
20081—032
20091—022
2010377021
20112—093
20122—0135
201361930177
20144960199
201541410179
201651730194
20170—0182
20180—0272
20190—0427
20202—0225
20211—1141
20220—0165
20230—0130
202432660236
20252—0244
20260—0—

What is it indicated for?

SURGISEAL 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 may be used in conjunction with, but not in place of, deep dermal sutures

Indications for use as stated in the FDA summary.

Also cleared against K082993

6 other devices cite the same predicate.

  • K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2016
  • K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
  • K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  • K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  • K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
  • K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013

More from Adhezion Biomedical, LLC

10 FDA decisions under this applicant name. See the company

  • K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2023
  • K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2017
  • K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2016
  • K150866SURGISEAL Topical Skin AdhesvieAdhezion Biomedical, LLC · 2015
  • K133963Surgiseal Twist (TM) Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014

Recent decisions in MPN

The MPN category page

  • K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc. · 2025
  • K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical · 2025
  • K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant Medical · 2024
  • K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd. · 2024
  • K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited. · 2024

https://510kreport.com/device/K140517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140517: Surgiseal Topical Skin Adhesive/Surgiseal Stylus 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/K140517

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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