DeviceClearance

K212323

Substantially Equivalent

Instinct Plus Endoscopic Clipping Device

Applicant
Wilson-Cook Medical, Inc.
Product code
PKL
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Winston-Salem, NC, 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.