510(k) K163455
K163455 is an FDA 510(k) premarket notification submitted by Surgicube International B.V. for the device "SurgiCube". The FDA issued a decision of Substantially Equivalent on Sep 28, 2017. The device falls under product code ORC (Air Filter Portable Apparatus), a Class II device regulated under 21 CFR 878.5070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2017
- Date Received
- Dec 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Air Filter Portable Apparatus
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type
- 510(k)
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.