Sulopenem SPM 2 µg

Sulopenem SPM 2 µg is an FDA 510(k)-cleared medical device (K251879) manufactured by Liofilchem. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2025. Regulation: 8.