Precision Point Biopsy Needle Guide— 510(k) K160414
Substantially EquivalentCorbin Clinical Resources, LLC
FDA 510(k) clearance K160414 for Precision Point Biopsy Needle Guide, Substantially Equivalent on 2016-08-01. Applicant: Corbin Clinical Resources, LLC.
Clearance details
- Applicant
- Corbin Clinical Resources, LLC
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cumberland, MD, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.