SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS— 510(k) K013641

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K013641 for SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS, Substantially Equivalent on 2002-01-29. Applicant: Senorx, Inc..

Clearance details

Applicant: Senorx, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2001-11-05
Decision date: 2002-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, 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.