X12 STERILE REFLECTIVE MARKER SPHERE— 510(k) K111443
Substantially EquivalentPinsco Inc. Dba B & L Engineering
FDA 510(k) clearance K111443 for X12 STERILE REFLECTIVE MARKER SPHERE, Substantially Equivalent on 2011-09-29. Applicant: Pinsco Inc. Dba B & L Engineering.
Clearance details
- Applicant
- Pinsco Inc. Dba B & L Engineering
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.