Resolution 360 ULTRA Clip— 510(k) K193424

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K193424 for Resolution 360 ULTRA Clip, Substantially Equivalent on 2020-09-01. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-10
Decision date: 2020-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
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.