OMD · Cutaneous Tissue Adhesive With Mesh
General, Plastic Surgery · 21 CFR 878.4011 · Class 2
Overview
| Product Code | OMD |
|---|---|
| Device Name | Cutaneous Tissue Adhesive With Mesh |
| Regulation | 21 CFR 878.4011 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. | Jul 15, 2024 | SESE |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | May 23, 2022 | SESE |
| K213512 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | Dec 7, 2021 | SESE |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | Jun 5, 2020 | SESE |
| K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | Sep 25, 2017 | SESE |
| K163645 | DERMABOND PRINEO Skin Closure System | Ethicon, LLC | Apr 21, 2017 | SESE |
| K152490 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | Nov 25, 2015 | SESE |
| K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | ETHICON, Inc. | Mar 10, 2014 | SESE |
| DEN090005 | PRINEO SKIN CLOSURE SYSTEM | Closure Medical Corp. | Apr 30, 2010 | DENG |
Top Applicants
- ETHICON, Inc. — 3 clearances
- Chemence Medical, Inc. — 2 clearances
- Advanced Medical Solutions Limited — 1 clearance
- Closure Medical Corp. — 1 clearance
- Connexicon Medical , Ltd. — 1 clearance
