FDA Product Code
FDA Product Code OMD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4011
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. | 2024-07-15 | Traditional | PDF ↗ |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | 2022-05-23 | Traditional | PDF ↗ |
| K213512 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2021-12-07 | Special | PDF ↗ |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2020-06-05 | Traditional | PDF ↗ |
| K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2017-09-25 | Abbreviated | PDF ↗ |
| K163645 | DERMABOND PRINEO Skin Closure System | Ethicon, LLC | 2017-04-21 | Traditional | PDF ↗ |
| K152490 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2015-11-25 | Traditional | PDF ↗ |
| K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | ETHICON, Inc. | 2014-03-10 | Special | PDF ↗ |
| DEN090005 | PRINEO SKIN CLOSURE SYSTEM | Closure Medical Corp. | 2010-04-30 | Post-NSE | — |
Product code OMD · Class II · General, Plastic Surgery. Data: openFDA.