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 Aesculap, Inc., Ethicon, Inc. and Chemence Medical, Inc..

36
Total
36
Cleared
194d
Avg days
2008
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 225d recently vs 190d historically

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 Oct 22, 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096
Ethicon, Inc.
General & Plastic Surgery · 86d
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 May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976
Aesculap, Inc.
General & Plastic Surgery · 316d
Cleared Feb 06, 2012
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959
Aesculap, Inc.
General & Plastic Surgery · 210d
Cleared May 04, 2010
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K100423
Ethicon, Inc.
General & Plastic Surgery · 77d

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 increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MPN Product Code

Recent submissions under MPN have taken an average of 225 days to reach a decision - up from 190 days historically. Manufacturers should account for longer review timelines in current project planning.

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