Clearance Summary
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 received FDA 510(k) clearance under submission number K251337, sponsored by Thermo Fisher Scientific (Oxoid Ltd.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-12-05.
- Submission: K251337
- Applicant / Sponsor: Thermo Fisher Scientific (Oxoid Ltd.)
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1620
- Decision date: 2025-12-05
Classification & Regulation
This clearance is catalogued under FDA product code JTN and 21 CFR 866.1620, within the Microbiology review panel as a Class II device.