Gepotidacin GEP 10 µg— 510(k) K261853

Substantially Equivalent

Liofilchem, Inc.

FDA 510(k) clearance K261853 for Gepotidacin GEP 10 µg, Substantially Equivalent on 2026-07-23. Applicant: Liofilchem, Inc.. Device class: 2.

Clearance details

Applicant: Liofilchem, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2026-06-03
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTN

K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ602026-07-24
K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)2026-05-11
K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP102025-12-05
K253105 — HardyDisk AST Cefiderocol 30µg (FDC30)2025-11-20
K251879 — Sulopenem SPM 2 µg2025-08-12

More clearances from Liofilchem, Inc.

K250885 — Ceftobiprole BPR 5 µg Disc2025-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.