Rotatable Snares— 510(k) K160637

Name: FDA 510(k) clearance K160637
Creator: U.S. Food and Drug Administration
Published: 2016-03-30

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K160637 for Rotatable Snares, Substantially Equivalent on 2016-03-30. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-07
Decision date: 2016-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.