Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Gepotidacin GEP 10 µg

K-Number: K261853 · 2026-07-23

ApplicantLiofilchem, Inc.
Decision Date2026-07-23
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Gepotidacin GEP 10 µg is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261853. 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 Gepotidacin GEP 10 µg?

Gepotidacin GEP 10 µg is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Liofilchem, Inc.. The 510(k) number is K261853.

When did Gepotidacin GEP 10 µg receive FDA 510(k) clearance?

Gepotidacin GEP 10 µg received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261853.

Who is the listed applicant for Gepotidacin GEP 10 µg?

The FDA 510(k) record lists Liofilchem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gepotidacin GEP 10 µg?

The FDA product code for Gepotidacin GEP 10 µg is JTN.

Other records listing Liofilchem, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251879Sulopenem SPM 2 µgK250885Ceftobiprole BPR 5 µg Disc

Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchemK250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics

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.

↑