SEL

Securement Wound Dressing For Reduction Of Infection

Product code

SEL

Device name

Securement Wound Dressing For Reduction Of Infection

Device class

Class U

Medical specialty

Unknown

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI).

Definition text from the FDA device classification database (U.S. federal government work, public domain).