MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086— 510(k) K030049

Substantially Equivalent

Rubicor Medical, Inc.

FDA 510(k) clearance K030049 for MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086, Substantially Equivalent on 2003-01-29. Applicant: Rubicor Medical, Inc..

Clearance details

Applicant: Rubicor Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2003-01-06
Decision date: 2003-01-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Carlos, CA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.