DeviceClearance

K222503

Substantially Equivalent

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

Applicant
Boston Scientific Corporation
Product code
PKL
Advisory panel
Gastroenterology, Urology
Date received
Decision date
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, through . 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.