RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537— 510(k) K071048

Substantially Equivalent

Rubicor Medical, Inc.

FDA 510(k) clearance K071048 for RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537, Substantially Equivalent on 2007-05-15. Applicant: Rubicor Medical, Inc..

Clearance details

Applicant: Rubicor Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-13
Decision date: 2007-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.