PRESTO BREAST BIOPSY DEVICE— 510(k) K133702

Substantially Equivalent

Sontina Medical, LLC

FDA 510(k) clearance K133702 for PRESTO BREAST BIOPSY DEVICE, Substantially Equivalent on 2014-02-28. Applicant: Sontina Medical, LLC.

Clearance details

Applicant: Sontina Medical, LLC
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-03
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, 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.