FDA Product Code
FDA Product Code ORC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5070
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190027 | SteriStay | Toul Meditech AB | 2019-05-10 | Traditional | PDF ↗ |
| K173349 | Operio | Toul Meditech AB | 2017-12-20 | Traditional | PDF ↗ |
| K163455 | SurgiCube | Surgicube International B.V. | 2017-09-28 | Traditional | PDF ↗ |
| K153498 | Operio | Toul Meditech AB | 2016-07-20 | Traditional | PDF ↗ |
| K123006 | AIR BARRIER SYSTEM (ABS) | Nimbic Systems, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K092801 | ABS BLOWER, ABS NOZZLE, MODEL 1001 | Nimbic Systems, LLC | 2011-05-20 | Traditional | PDF ↗ |
Product code ORC · Class II · General, Plastic Surgery. Data: openFDA.