Clearance Summary
X12 STERILE REFLECTIVE MARKER SPHERE received FDA 510(k) clearance under submission number K111443, sponsored by Pinsco Inc. Dba B & L Engineering. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-09-29.
- Submission: K111443
- Applicant / Sponsor: Pinsco Inc. Dba B & L Engineering
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2011-09-29
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.