HardyDisk AST Gepotidacin 10µg (GEP10)
K-Number: K260842 · 2026-05-11
ApplicantHardy Diagnostics
Decision Date2026-05-11
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Gepotidacin 10µg (GEP10) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2026-05-11 under approval number K260842. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HardyDisk AST Gepotidacin 10µg (GEP10)?
HardyDisk AST Gepotidacin 10µg (GEP10) is a medical device that received FDA 510(k) clearance on 2026-05-11. It is manufactured by Hardy Diagnostics. The 510(k) number is K260842.
When was HardyDisk AST Gepotidacin 10µg (GEP10) approved by the FDA?
HardyDisk AST Gepotidacin 10µg (GEP10) received FDA 510(k) clearance on 2026-05-11, under approval number K260842.
What company makes HardyDisk AST Gepotidacin 10µg (GEP10)?
HardyDisk AST Gepotidacin 10µg (GEP10) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Gepotidacin 10µg (GEP10)?
The FDA product code for HardyDisk AST Gepotidacin 10µg (GEP10) is JTN.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.