Cutaneous Tissue Adhesive With Mesh
OMD is the FDA product code for Cutaneous Tissue Adhesive With Mesh, a class II device type, regulated under 21 CFR 878.4011. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OMD
- Device name
- Cutaneous Tissue Adhesive With Mesh
- 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.
- Regulation
- 21 CFR 878.4011
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 0
Clearances, product code OMD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code OMD| Applicant | Clearances |
|---|---|
| Ethicon, Inc | 4 |
| Chemence Medical Inc. | 2 |
| Advanced Medical Solutions Limited | 1 |
| Closure Medical Corp. | 1 |
| Connexicon Medical, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
