K250066

Substantially Equivalent

Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)

Applicant: Boston Scientific Corporation
Product code: PKL
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-10
Decision date: 2025-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.