Clearance Summary
PIXEL APP received FDA 510(k) clearance under submission number K121274, sponsored by Gauss Surgical, Inc.,. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-06-27.
- Submission: K121274
- Applicant / Sponsor: Gauss Surgical, Inc.,
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2740
- Decision date: 2012-06-27
Classification & Regulation
This clearance is catalogued under FDA product code LWH and 21 CFR 880.2740, within the General Hospital review panel as a Class I device.