Puritan Fecal Opti-Swab Collection and Transport System

Puritan Fecal Opti-Swab Collection and Transport System is an FDA 510(k)-cleared medical device (K162284) manufactured by Puritan Medical Products, LLC. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 3, 2016. Regulation: 8.