ORC — Air Filter Portable Apparatus Class II
FDA product code ORC covers "Air Filter Portable Apparatus", a Class II medical device regulated under 21 CFR 878.5070. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ORC
- Device Class
- Class II
- Regulation Number
- 878.5070
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190027 | toul meditech | SteriStay | May 10, 2019 |
| K173349 | toul meditech | Operio | December 20, 2017 |
| K163455 | surgicube international | SurgiCube | September 28, 2017 |
| K153498 | toul meditech | Operio | July 20, 2016 |
| K123006 | nimbic systems | AIR BARRIER SYSTEM (ABS) | December 20, 2013 |
| K092801 | nimbic systems | ABS BLOWER, ABS NOZZLE, MODEL 1001 | May 20, 2011 |