DeviceClearance

K200320

Substantially Equivalent

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

Applicant
M/s. Meril Endo Surgery Private Limited.
Product code
GDW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chala, Vapi, IN
Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

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.