Resolution Clip (6 models)— 510(k) K250066

Name: FDA 510(k) clearance K250066
Creator: U.S. Food and Drug Administration
Published: 2025-02-06

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K250066 for Resolution Clip (6 models), Substantially Equivalent on 2025-02-06. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Device name as filed: Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
Applicant: Boston Scientific Corporation
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
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 ↗

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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.