DeviceClearance

K003102

Substantially Equivalent

PARE ENDOSCOPIC SUTURING SYSTEM

Applicant
Pare Surgical, Inc.
Product code
OCW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW
Death
6
Injury
443
Malfunction
1,023
Other
2
Total
1,474

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.