MPN · Tissue Adhesive For The Topical Approximation Of Skin
General, Plastic Surgery · 21 CFR 878.4010 · Class 2
Overview
| Product Code | MPN |
|---|---|
| Device Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Regulation | 21 CFR 878.4010 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b) *Tissue adhesive for non-topical use* —(1)*Identification.* A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243990 | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | Sep 19, 2025 | SESE |
| K250950 | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739) | Okapi Medical, LLC Dba Resivant Medical | Aug 4, 2025 | SESE |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Okapi Medical, LLC Dba Resivant Medical | Aug 20, 2024 | SESE |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical , Ltd. | Jul 15, 2024 | SESE |
| K230981 | Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. | Mar 16, 2024 | SESE |
| K212246 | Exofin Precision Pen | Chemence Medical, Inc. | Sep 9, 2021 | SESE |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical, Inc. | Dec 17, 2020 | SESE |
| K183570 | LiquiBand Plus | Advanced Medical Solutions Limited | Mar 9, 2020 | SESE |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | Chemence Medical, Inc. | Dec 22, 2016 | SESE |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive | Adhezion Biomedical, LLC | Nov 8, 2016 | SESE |
| K161050 | ACTABOND Topical Skin Adhesive | Bergen Medical Products, Inc. | Oct 4, 2016 | SESE |
| K152476 | Exofin High Viscosity Tissue Adhesive | Chemence Medical Products, Inc. | Feb 9, 2016 | SESE |
| K150032 | GluStitch Twist Tissue Adhesive | Glustitch, Inc. | Jan 14, 2016 | SESE |
| K141157 | BONDEASE TOPICAL SKIN ADHESIVE | Optmed, Inc. | Dec 22, 2015 | SESE |
| K151182 | LiquiBand Exceed | Advanced Medical Solutions (Plymouth), Ltd. | Oct 26, 2015 | SESE |
| K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | ETHICON, Inc. | Oct 22, 2015 | SESE |
| K150866 | SURGISEAL Topical Skin Adhesvie | Adhezion Biomedical, LLC | Jul 17, 2015 | SESE |
| K133963 | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | Sep 9, 2014 | SESE |
| K141215 | SURGISEAL TWIST TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | Aug 21, 2014 | SESE |
| K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP | Aesculap, Inc. | May 13, 2014 | SESE |
Top Applicants
- Adhezion Biomedical, LLC — 8 clearances
- Advanced Medical Solutions (Plymouth), Ltd. — 4 clearances
- Medlogic Global Limited — 3 clearances
- Chemence Medical, Inc. — 3 clearances
- Aesculap, Inc. — 3 clearances
