DeviceClearance

K841618

Substantially Equivalent

THREADING TUBE

Applicant
Plastafil, Inc.
Product code
FZX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FZX

product code FZX
Injury
797
Malfunction
3,815
Total
4,612

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.