Product Code: MPN
FDA class 2
21 CFR 878.4010
Tissue Adhesive For The Topical Approximation Of Skin
General, Plastic Surgery
The Tissue Adhesive for Topical Approximation of Skin is a general surgery device used to close minor lacerations and surgical incisions by bonding wound edges together without sutures or staples, analogous to a medical-grade glue. Reclassified from Class 3 PMA to Class 2 510(k) in May 2008, it is now regulated under 21 CFR 878.4010 in the General and Plastic Surgery specialty. The product code is MPN.
510(k)s
34
FEI Numbers
34
Registration Numbers
34
Unique Applicants
19
Years Active
16
Basic Information
- Product Code
- MPN
- Device Class
- FDA class 2
- Regulation Number
- 878.4010
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 34 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Aug 20, 2024 | Substantially Equivalent | Okapi Medical LLC dba Resivant Medical |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Jul 15, 2024 | Substantially Equivalent | Connexicon Medical Ltd. |
| K230981 | Meriglu Topical Skin Adhesive | Mar 16, 2024 | Substantially Equivalent | M/s Meril Endo Surgery Private Limited |
| K212246 | Exofin Precision Pen | Sep 09, 2021 | Substantially Equivalent | Chemence Medical, Inc. |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Dec 17, 2020 | Substantially Equivalent | Chemence Medical, Inc. |
| K183570 | LiquiBand Plus | Mar 09, 2020 | Substantially Equivalent | Advanced Medical Solutions Limited |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | Dec 22, 2016 | Substantially Equivalent | CHEMENCE MEDICAL INC |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive | Nov 08, 2016 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K161050 | ACTABOND Topical Skin Adhesive | Oct 04, 2016 | Substantially Equivalent | BERGEN MEDICAL PRODUCTS, INC. |
| K152476 | Exofin High Viscosity Tissue Adhesive | Feb 09, 2016 | Substantially Equivalent | CHEMENCE MEDICAL PRODUCTS INC. |
| K150032 | GluStitch Twist Tissue Adhesive | Jan 14, 2016 | Substantially Equivalent | GLUSTITCH, INC. |
| K141157 | BONDEASE TOPICAL SKIN ADHESIVE | Dec 22, 2015 | Substantially Equivalent | OPTMED, INC. |
| K151182 | LiquiBand Exceed | Oct 26, 2015 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | Oct 22, 2015 | Substantially Equivalent | Ethicon, Inc. |
| K150866 | SURGISEAL Topical Skin Adhesvie | Jul 17, 2015 | Substantially Equivalent | ADHEZION BIOMEDICAL, LLC |
| K133963 | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE | Sep 09, 2014 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K141215 | SURGISEAL TWIST TOPICAL SKIN ADHESIVE | Aug 21, 2014 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP | May 13, 2014 | Substantially Equivalent | AESCULAP, INC. |
| K140517 | SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE | Apr 28, 2014 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K132243 | BARLE TISSUE ADHESIVE 2 | Dec 20, 2013 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| K130329 | SURGISEAL TOPICAL SKIN ADHESIVE | Dec 03, 2013 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K130474 | SURGISEAL TOPICAL SKIN ADHESIVE | May 31, 2013 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K123133 | BARLE TISSUE ADHESIVE | May 22, 2013 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| K121976 | AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE | May 17, 2013 | Substantially Equivalent | AESCULAP, INC. |
| K123936 | SURGISEAL TOPICAL SKIN ADHESIVE | Apr 24, 2013 | Substantially Equivalent | Adhezion Biomedical, LLC |
| K122446 | LIQUIDBAND FLOW CONTROL | Oct 26, 2012 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| K111959 | AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE | Feb 06, 2012 | Substantially Equivalent | AESCULAP, INC. |
| K110184 | LIQUIBAND FLOW CONTROL | Dec 16, 2011 | Substantially Equivalent | MEDLOGIC GLOBAL LIMITED |
| K102076 | LIQUIBAND DUAL, MODEL LBD 001 | Feb 18, 2011 | Substantially Equivalent | MEDLOGIC GLOBAL LIMITED |
| K101276 | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 | Jul 28, 2010 | Substantially Equivalent | CHEMENCE MEDICAL PRODUCTS INC. |
| K100423 | DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 | May 04, 2010 | Substantially Equivalent | ETHICON, INC. |
| K100284 | LIQUIBAND ULTIMA, LUT 003 | Apr 09, 2010 | Substantially Equivalent | MEDLOGIC GLOBAL LIMITED |
| K083531 | LIQUIBAND ULTIMA, MODEL LB0004 | Feb 12, 2009 | Substantially Equivalent | MEDLOGIC GLOBAL LTD. |
| K082993 | SURGISEAL TOPICAL SKIN ADHESIVE | Dec 19, 2008 | Substantially Equivalent | ADHEZION BIOMEDICAL |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.