Cleared Traditional

Thermo Scientific Oxoid Gepotidacin Disc (10 ?g) GEP10

K251337 · Thermo Fisher Scientific (Oxoid Ltd.) · Microbiology

Dec 2025

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K251337 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Gepotidacin Disc (10 ?g) GEP10, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Thermo Fisher Scientific (Oxoid Ltd.) (Basingstroke, GB). The FDA issued a Cleared decision on December 5, 2025, 219 days after receiving the submission on April 30, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K251337 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	December 05, 2025
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement