Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

FDA 510(k) K251337 · Thermo Fisher Scientific (Oxoid Ltd.)

Substantially Equivalent

510(k) numberK251337

Submission

Device name
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
Applicant
Thermo Fisher Scientific (Oxoid Ltd.)
Basingstoke, GB
Received
April 30, 2025
Decision date
December 5, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JTN – Susceptibility Test Discs, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1620
Specialty
Microbiology

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K250885Ceftobiprole BPR 5 µg DiscJTN · Traditional Liofilchem, Inc.06/23/2025SE
K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional Thermo Fisher Scientific (Oxoid Ltd.)06/12/2025SE
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More from Hardy Diagnostics

510(k)DeviceDecision
K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional 07/24/2026SE
K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional 06/12/2025SE

Questions and answers

When was Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 cleared by the FDA?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (K251337) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 219 days after the submission was received.

What is the product code of K251337?

The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.