EASY CORE DETACHABLE BIOPSY SYSTEM— 510(k) K051361

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K051361 for EASY CORE DETACHABLE BIOPSY SYSTEM, Substantially Equivalent on 2005-06-16. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2005-05-25
Decision date: 2005-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, 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.