SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS— 510(k) K021707

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K021707 for SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS, Substantially Equivalent on 2002-08-14. Applicant: Senorx, Inc..

Clearance details

Applicant: Senorx, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2002-05-23
Decision date: 2002-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

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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.