DeviceClearance

K082097

Substantially Equivalent

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

Applicant
Demetech Corp.
Product code
NEW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NEW

product code NEW
Death
32
Injury
2,179
Malfunction
8,975
Total
11,186

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.