510(k) K260696

MTS Gepotidacin 0.016-256 µg/mL by Liofilchem s.r.l. — Product Code JWY

K260696 is an FDA 510(k) premarket notification submitted by Liofilchem s.r.l. for the device "MTS Gepotidacin 0.016-256 µg/mL". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Liofilchem s.r.l. has at least 10 other 510(k) clearances on record.