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

Name: FDA 510(k) clearance K030049
Creator: U.S. Food and Drug Administration
Published: 2003-01-29

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.. Device class: 2.

Clearance details

Applicant: Rubicor Medical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
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

Download summary PDF View on FDA.gov ↗

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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.