MPN — Tissue Adhesive For The Topical Approximation Of Skin Class II
FDA product code MPN covers "Tissue Adhesive For The Topical Approximation Of Skin", a Class II medical device regulated under 21 CFR 878.4010. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MPN
- Device Class
- Class II
- Regulation Number
- 878.4010
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243990 | optmed | BondEase 2 Topical Skin Adhesive | September 19, 2025 |
| K250950 | okapi medical, llc dba resivant medical | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739 | August 4, 2025 |
| K234114 | okapi medical, llc dba resivant medical | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System | August 20, 2024 |
| K233458 | connexicon medical | CM005 Standard (CM005); CM004 Mini (CM004) | July 15, 2024 |
| K230981 | m/s. meril endo surgery private limited | Meriglu Topical Skin Adhesive | March 16, 2024 |
| K212246 | chemence medical | Exofin Precision Pen | September 9, 2021 |
| K200264 | chemence medical | Exofin High Viscosity Topical Skin Adhesive | December 17, 2020 |
| K183570 | advanced medical solutions limited | LiquiBand Plus | March 9, 2020 |
| K162352 | chemence medical | derma+flex QS High Viscosity Tissue Adhesive | December 22, 2016 |
| K161011 | adhezion biomedical | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISE | November 8, 2016 |
| K161050 | bergen medical products | ACTABOND Topical Skin Adhesive | October 4, 2016 |
| K152476 | chemence medical products | Exofin High Viscosity Tissue Adhesive | February 9, 2016 |
| K150032 | glustitch | GluStitch Twist Tissue Adhesive | January 14, 2016 |
| K141157 | optmed | BONDEASE TOPICAL SKIN ADHESIVE | December 22, 2015 |
| K151182 | advanced medical solutions (plymouth) | LiquiBand Exceed | October 26, 2015 |
| K152096 | ethicon | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical | October 22, 2015 |
| K150866 | adhezion biomedical | SURGISEAL Topical Skin Adhesvie | July 17, 2015 |
| K133963 | adhezion biomedical | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE | September 9, 2014 |
| K141215 | adhezion biomedical | SURGISEAL TWIST TOPICAL SKIN ADHESIVE | August 21, 2014 |
| K140343 | aesculap | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHES | May 13, 2014 |