Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip— 510(k) K222503

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K222503 for Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip, Substantially Equivalent on 2022-09-14. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-18
Decision date: 2022-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, 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.