510(k) Report

510(k) · Cleared

Cleared

Surgiseal Twist Topical Skin Adhesive

K141215510(k) TraditionalCleared Aug 21, 2014101-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 Aug 21, 2014 as substantially equivalent to K082993 (Adhezion Biomedical, 2008) and 4 other predicates after a 101-day review. Its family tree reaches back 6 generations to 2002.

Decided
Aug 21, 2014
Review
101 days
Class
Class II
Product code
MPN
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to P010002 (2002). 13 ancestors in all, the oldest P960052 (1998). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 3 other ancestors2008: 1 other ancestor2010: 2 other ancestors1998: 1 other ancestorP010002 · 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 · recalledK140517 · Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive · Adhezion Biomedical, LLC · 201419952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K140517 · Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive · Adhezion Biomedical, LLC · 2014K122446 · 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 · 6 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
  2. 5 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
  3. 4 generations backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
  4. 3 generations backK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
  5. 2 generations backK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · Recalled
  6. 1 generation backK140517 Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
  7. This deviceK141215 Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6P010002Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States2002—
−5K083531Liquiband Ultima, Model LB0004Medlogic Global, Ltd.2009—
−4K100284Liquiband Ultima, Lut 003Medlogic Global Limited2010—
−3K110184Liquiband Flow ControlMedlogic Global Limited2011—
−2K122446Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd.20121
−1K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC2014—
0 (this device)K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200810
201020
201330
FIG. 1 — Lineage of K141215, 2002–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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 4
…al and Plastic Surgery Devices Regulation Class II, under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, device(s) to which K140517) equivalence is SURGISEAL Stylus™ Topical Skin Adhesive (K130474, K1405…
Adhezion Biomedical2008—
*K123936Surgiseal Topical Skin Adhesive
Summary page 4
…astic Surgery Devices Regulation Class II, under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, device(s) to which K140517) equivalence is SURGISEAL Stylus™ Topical Skin Adhesive (K130474, K140517) claim…
Adhezion Biomedical, LLC2013—
*K130329Surgiseal Topical Skin Adhesive
Summary page 4
…gery Devices Regulation Class II, under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, device(s) to which K140517) equivalence is SURGISEAL Stylus™ Topical Skin Adhesive (K130474, K140517) claimed…
Adhezion Biomedical, LLC2013—
*K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin Adhesive
Summary page 4
…Class II, under 21 CFR 878.4010 Product Code(s) MPN Legally Marketed SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, device(s) to which K140517) equivalence is SURGISEAL Stylus™ Topical Skin Adhesive (K130474, K140517) claimed SURGISEAL Twist…
Adhezion Biomedical, LLC2014—
*K130474Surgiseal Topical Skin Adhesive
Summary page 4
…rketed SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, device(s) to which K140517) equivalence is SURGISEAL Stylus™ Topical Skin Adhesive (K130474, K140517) claimed SURGISEAL Twist™ Topical Skin Adhesive (K130474) Reason for 510(k) Labeling Change t…
Adhezion Biomedical, LLC2013—

Also cleared against K082993: 6 other devices →

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?

  • 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 13 ancestors have a recall of any class.
  • 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
  • K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus 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/K141215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141215: 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/K141215

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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