510(k) K251337

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 by Thermo Fisher Scientific (Oxoid Ltd.) — Product Code JTN

K251337 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific (Oxoid Ltd.) for the device "Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Thermo Fisher Scientific (Oxoid Ltd.) has at least 1 other 510(k) clearance on record.