MPN · Class II · 21 CFR 878.4010

FDA Product Code MPN: Tissue Adhesive For The Topical Approximation Of Skin

Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).

Leading manufacturers include Adhezion Biomedical, LLC, Advanced Medical Solutions (Plymouth), Ltd. and Medlogic Global Limited.

36
Total
36
Cleared
194d
Avg days
2008
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 198d avg (recent)

FDA 510(k) Cleared Tissue Adhesive For The Topical Approximation Of Skin Devices (Product Code MPN)

36 devices
1–24 of 36
Cleared Sep 19, 2025
BondEase 2 Topical Skin Adhesive
K243990
Optmed, Inc.
General & Plastic Surgery · 267d
Cleared Aug 04, 2025
CUTIVA™ Topical Skin Adhesive (RM1700)
K250950
Okapi Medical, LLC Dba Resivant Medical
General & Plastic Surgery · 129d
Cleared Aug 20, 2024
CUTIVA(TM) Topical Skin Adhesive (RM-1700)
K234114
Okapi Medical, LLC Dba Resivant Medical
General & Plastic Surgery · 237d
Cleared Jul 15, 2024
CM005 Standard (CM005)
K233458
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared Mar 16, 2024
Meriglu Topical Skin Adhesive
K230981
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 346d
Cleared Sep 09, 2021
Exofin Precision Pen
K212246
Chemence Medical, Inc.
General & Plastic Surgery · 52d
Cleared Dec 17, 2020
Exofin High Viscosity Topical Skin Adhesive
K200264
Chemence Medical, Inc.
General & Plastic Surgery · 318d
Cleared Mar 09, 2020
LiquiBand Plus
K183570
Advanced Medical Solutions Limited
General & Plastic Surgery · 444d
Cleared Dec 22, 2016
derma+flex QS High Viscosity Tissue Adhesive
K162352
Chemence Medical, Inc.
General & Plastic Surgery · 121d
Cleared Nov 08, 2016
SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
K161011
Adhezion Biomedical, LLC
General & Plastic Surgery · 211d
Cleared Oct 04, 2016
ACTABOND Topical Skin Adhesive
K161050
Bergen Medical Products, Inc.
General & Plastic Surgery · 173d
Cleared Feb 09, 2016
Exofin High Viscosity Tissue Adhesive
K152476
Chemence Medical Products, Inc.
General & Plastic Surgery · 162d
Cleared Jan 14, 2016
GluStitch Twist Tissue Adhesive
K150032
Glustitch, Inc.
General & Plastic Surgery · 371d
Cleared Dec 22, 2015
BONDEASE TOPICAL SKIN ADHESIVE
K141157
Optmed, Inc.
General & Plastic Surgery · 596d
Cleared Oct 26, 2015
LiquiBand Exceed
K151182
Advanced Medical Solutions (Plymouth), Ltd.
General & Plastic Surgery · 175d
Cleared Oct 22, 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Jul 17, 2015
SURGISEAL Topical Skin Adhesvie
K150866
Adhezion Biomedical, LLC
General & Plastic Surgery · 107d
Cleared Sep 09, 2014
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963
Adhezion Biomedical, LLC
General & Plastic Surgery · 259d
Cleared Aug 21, 2014
SURGISEAL TWIST TOPICAL SKIN ADHESIVE
K141215
Adhezion Biomedical, LLC
General & Plastic Surgery · 101d
Cleared May 13, 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
K140343
Aesculap, Inc.
General & Plastic Surgery · 91d
Cleared Apr 28, 2014
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
K140517
Adhezion Biomedical, LLC
General & Plastic Surgery · 59d
Cleared Dec 20, 2013
BARLE TISSUE ADHESIVE 2
K132243
Advanced Medical Solutions (Plymouth), Ltd.
General & Plastic Surgery · 155d
Cleared Dec 03, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130329
Adhezion Biomedical, LLC
General & Plastic Surgery · 295d
Cleared May 31, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130474
Adhezion Biomedical, LLC
General & Plastic Surgery · 95d

About Product Code MPN - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code MPN since 2008, with 36 receiving FDA clearance (average review time: 194 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - MPN Product Code

FDA review times for MPN submissions have been consistent, averaging 198 days recently vs 194 days historically.

MPN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →