Device |
cutaneous tissue adhesive with mesh |
Regulation Description |
Tissue adhesive with adjunct wound closure device for topical approximation of skin. |
Definition |
For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures. |
Physical State |
1) A liquid adhesive and 2) A self-adhering initiated mesh athat is packaged within an applicator |
Technical Method |
Adhesive to hold closed skin edges of wounds |
Target Area |
The device is meant to act topically on the skin |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | OMD |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.4011
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |