Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device— 510(k) K160845

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K160845 for Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, Substantially Equivalent on 2016-05-03. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-28
Decision date: 2016-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.