FDA product code OMD: Cutaneous Tissue Adhesive With Mesh
OMD is the FDA product code for cutaneous tissue adhesive with mesh. It is a Class II device, regulated under 21 CFR 878.4011 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under OMD, 2 in the last five years, from 5 different applicants. The average 510(k) review took 178 days (median 126); 266 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cutaneous Tissue Adhesive With Mesh |
| Device class | Class II |
| Regulation | 21 CFR 878.4011 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OMD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 126 |
| 2020 | 1 | 368 |
| 2021 | 1 | 35 |
| 2022 | 1 | 336 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every OMD clearance
Top OMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 3 | 2021-12-07 |
| Chemence Medical, Inc. | 2 | 2020-06-05 |
| Connexicon Medical , Ltd. | 1 | 2024-07-15 |
| Advanced Medical Solutions Limited | 1 | 2022-05-23 |
| Ethicon, LLC | 1 | 2017-04-21 |
Most recent OMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233460 | Connexicon Medical , Ltd. | CM00622 LINC Skin Closure System (CM00622 LINC) | 2024-07-15 | 266 |
| K211878 | Advanced Medical Solutions Limited | LiquiBand XL | 2022-05-23 | 336 |
| K213512 | ETHICON, Inc. | DERMABOND PRINEO Skin Closure System | 2021-12-07 | 35 |
| K191461 | Chemence Medical, Inc. | Exofin Fusion Skin Closure System | 2020-06-05 | 368 |
| K171442 | Chemence Medical, Inc. | Exofin Fusion Skin Closure System | 2017-09-25 | 132 |
Recalls for OMD devices
openFDA lists no recalls for product code OMD.
Frequently asked questions
What is FDA product code OMD?
OMD is the FDA product code for cutaneous tissue adhesive with mesh. It is a Class II device, regulated under 21 CFR 878.4011 and reviewed by the General and Plastic Surgery panel.
What device class is OMD?
Class II, regulation 21 CFR 878.4011. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMD?
Across 8 cleared submissions the average was 178 days from receipt to decision (median 126).
Which companies have the most OMD clearances?
ETHICON, Inc. (3); Chemence Medical, Inc. (2); Connexicon Medical , Ltd. (1); Advanced Medical Solutions Limited (1); Ethicon, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMD
- Run a recall and safety report across every OMD manufacturer
- Watch product code OMD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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