FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) is an FDA 510(k)-cleared medical device (K091681) manufactured by Entellus Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 7, 2009. Regulation: 8.