Source document or public record
FDA 510(k) K261853 — Gepotidacin GEP 10 µg
FDA 510(k) index record K261853. Device: Gepotidacin GEP 10 µg. Applicant as listed: Liofilchem, Inc.. Decision date: 2026-07-23.
Source
"device_name": "Gepotidacin GEP 10 µg"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K261853.
Device name: Gepotidacin GEP 10 µg. Applicant as listed: Liofilchem, Inc..
Decision date: 2026-07-23. Decision wording: Substantially Equivalent.
Product code: JTN. Regulation: 21 CFR 866.1620. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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