DeviceClearance

K110647

Substantially Equivalent

RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS

Applicant
Smith & Nephew, Inc.
Product code
OMP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Petersburg, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP
Death
31
Injury
1,707
Malfunction
4,047
Other
1
Total
5,786

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.