Atlas FDA

MPN

36 FDA 510(k) clearances · Product code

173 daysmedian time to decision
346 days90th percentile
36clearances measured

FDA profile

Official device name
Tissue Adhesive For The Topical Approximation Of Skin
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4010
Medical specialty
General, Plastic Surgery
FDA definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Adverse events (MAUDE)
2021: 141 · 2022: 165 · 2023: 130 · 2024: 236 · 2025: 246 · 2026: 139
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BondEase 2 Topical Skin Adhesive (K243990)Optmed, Inc.2025-09-19
CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950)Okapi Medical, LLC Dba Resivant Medical2025-08-04
CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) (K234114)Okapi Medical, LLC Dba Resivant Medical2024-08-20
CM005 Standard (CM005); CM004 Mini (CM004) (K233458)Connexicon Medical , Ltd.2024-07-15
Meriglu Topical Skin Adhesive (K230981)M/s. Meril Endo Surgery Private Limited.2024-03-16
Exofin Precision Pen (K212246)Chemence Medical, Inc.2021-09-09
Exofin High Viscosity Topical Skin Adhesive (K200264)Chemence Medical, Inc.2020-12-17
LiquiBand Plus (K183570)Advanced Medical Solutions Limited2020-03-09
derma+flex QS High Viscosity Tissue Adhesive (K162352)Chemence Medical, Inc.2016-12-22
SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive (K161011)Adhezion Biomedical, LLC2016-11-08
ACTABOND Topical Skin Adhesive (K161050)Bergen Medical Products, Inc.2016-10-04
Exofin High Viscosity Tissue Adhesive (K152476)Chemence Medical Products, Inc.2016-02-09
GluStitch Twist Tissue Adhesive (K150032)Glustitch, Inc.2016-01-14
BONDEASE TOPICAL SKIN ADHESIVE (K141157)Optmed, Inc.2015-12-22
LiquiBand Exceed (K151182)Advanced Medical Solutions (Plymouth), Ltd.2015-10-26
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive (K152096)ETHICON, Inc.2015-10-22
SURGISEAL Topical Skin Adhesvie (K150866)Adhezion Biomedical, LLC2015-07-17
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE (K133963)Adhezion Biomedical, LLC2014-09-09
SURGISEAL TWIST TOPICAL SKIN ADHESIVE (K141215)Adhezion Biomedical, LLC2014-08-21
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP (K140343)Aesculap, Inc.2014-05-13
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE (K140517)Adhezion Biomedical, LLC2014-04-28
BARLE TISSUE ADHESIVE 2 (K132243)Advanced Medical Solutions (Plymouth), Ltd.2013-12-20
SURGISEAL TOPICAL SKIN ADHESIVE (K130329)Adhezion Biomedical, LLC2013-12-03
SURGISEAL TOPICAL SKIN ADHESIVE (K130474)Adhezion Biomedical, LLC2013-05-31
BARLE TISSUE ADHESIVE (K123133)Advanced Medical Solutions (Plymouth), Ltd.2013-05-22
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE (K121976)Aesculap, Inc.2013-05-17
SURGISEAL TOPICAL SKIN ADHESIVE (K123936)Adhezion Biomedical, LLC2013-04-24
LIQUIDBAND FLOW CONTROL (K122446)Advanced Medical Solutions (Plymouth), Ltd.2012-10-26
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE (K111959)Aesculap, Inc.2012-02-06
LIQUIBAND FLOW CONTROL (K110184)Medlogic Global Limited2011-12-16
LIQUIBAND DUAL, MODEL LBD 001 (K102076)Medlogic Global Limited2011-02-18
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 (K101276)Chemence Medical Products, Inc.2010-07-28
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 (K100423)ETHICON, Inc.2010-05-04
LIQUIBAND ULTIMA, LUT 003 (K100284)Medlogic Global Limited2010-04-09
LIQUIBAND ULTIMA, MODEL LB0004 (K083531)Medlogic Global , Ltd.2009-02-12
SURGISEAL TOPICAL SKIN ADHESIVE (K082993)Adhezion Biomedical2008-12-19

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