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
| Device Type ID | 5813 |
| Device Name | Cutaneous Tissue Adhesive With Mesh |
| 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 Description | Tissue Adhesive With Adjunct Wound Closure Device For Topical Approximation Of Skin. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4011 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5813 |
| Device | Cutaneous Tissue Adhesive With Mesh |
| Product Code | OMD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tissue Adhesive With Adjunct Wound Closure Device For Topical Approximation Of Skin. |
| CFR Regulation Number | 878.4011 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ETHICON, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 333 |
Device Markings / Labelling Problem | 65 |
Adverse Event Without Identified Device Or Use Problem | 13 |
Tear, Rip Or Hole In Device Packaging | 6 |
Failure To Adhere Or Bond | 2 |
Reaction | 2 |
Incorrect Device Or Component Shipped | 2 |
Unsealed Device Packaging | 2 |
Material Erosion | 1 |
Break | 1 |
Insufficient Information | 1 |
| Total Device Problems | 428 |