DeviceClearance

K951352

Substantially Equivalent

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE

Applicant
Davis & Geck, Inc.
Product code
GAM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danbury, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM
Death
45
Injury
5,711
Malfunction
30,744
Other
4
Total
36,504

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.