DeviceClearance

K840976

Substantially Equivalent

VARIOUS DISPOSABLE KITS/TRAYS/INSTRU

Applicant
Carapace, Inc.
Product code
FSM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FSM

product code FSM
Malfunction
1,289
Total
1,289

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.