15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE— 510(k) K993936

Substantially Equivalent

Imagyn Surgical

FDA 510(k) clearance K993936 for 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE, Substantially Equivalent on 1999-12-27. Applicant: Imagyn Surgical.

Clearance details

Applicant: Imagyn Surgical
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1999-11-19
Decision date: 1999-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, 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.