Device class
Class II
Regulation 878.4011
Total clearances
4
2020-06-05 → 2024-07-15
Definition
What is Cutaneous Tissue Adhesive With Mesh
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.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4011
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 12001 |
CPT
|
— |
High
|
Repair of superficial wounds with simple closure; tissue adhesive with mesh for wound approximation |
| 12011 |
CPT
|
— |
Medium
|
Repair of superficial lacerations with closure alternative to sutures; tissue adhesive application code |
Pulse
Most recent 510(k) clearances