OMD
9 FDA 510(k) clearances · Product code
132 daysmedian time to decision
402 days90th percentile
9clearances measured
FDA profile
- Official device name
- Cutaneous Tissue Adhesive With Mesh
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4011
- Medical specialty
- General, Plastic Surgery
- FDA 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.
- Adverse events (MAUDE)
- 2021: 186 · 2022: 175 · 2023: 171 · 2024: 256 · 2025: 295 · 2026: 133
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CM00622 LINC Skin Closure System (CM00622 LINC) (K233460) | Connexicon Medical , Ltd. | 2024-07-15 |
| LiquiBand XL (K211878) | Advanced Medical Solutions Limited | 2022-05-23 |
| DERMABOND PRINEO Skin Closure System (K213512) | ETHICON, Inc. | 2021-12-07 |
| Exofin Fusion Skin Closure System (K191461) | Chemence Medical, Inc. | 2020-06-05 |
| Exofin Fusion Skin Closure System (K171442) | Chemence Medical, Inc. | 2017-09-25 |
| DERMABOND PRINEO Skin Closure System (K163645) | Ethicon, LLC | 2017-04-21 |
| DERMABOND PRINEO Skin Closure System (K152490) | ETHICON, Inc. | 2015-11-25 |
| DERMABOND PRINEO SKIN CLOSURE SYSTEM (K133864) | ETHICON, Inc. | 2014-03-10 |
| PRINEO SKIN CLOSURE SYSTEM (DEN090005) | Closure Medical Corp. | 2010-04-30 |
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Every clearance here is in the API, with alerts when new ones post.