BEXCORE Breast Biopsy System, Biopsy Needle— 510(k) K171890

Substantially Equivalent

Medical Park Co., Ltd.

FDA 510(k) clearance K171890 for BEXCORE Breast Biopsy System, Biopsy Needle, Substantially Equivalent on 2018-08-20. Applicant: Medical Park Co., Ltd..

Clearance details

Applicant: Medical Park Co., Ltd.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-26
Decision date: 2018-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

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.