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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261853

510(k) cleared

Gepotidacin GEP 10 µg

Liofilchem, Inc. · Jul 23, 2026 · K261853

FDA cleared the Gepotidacin GEP 10 µg from Liofilchem, Inc. on Jul 23, 2026 under K261853, a traditional 510(k). The device falls under product code JTN, Susceptibility Test Discs, Antimicrobial, regulated at 21 CFR 866.1620 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 3, 2026. The decision came 50 days later, inside the 90 FDA-day goal for a 510(k).

Liofilchem, Inc. has 2 other decisions in the tracker over the last 12 months: K260696 (MTS Gepotidacin 0.016-256 µg/mL), K252114 (MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL).

Questions & Answers

What did FDA clear under K261853?

K261853 is the FDA 510(k) for Gepotidacin GEP 10 µg, submitted by Liofilchem, Inc.. FDA's decision date was Jul 23, 2026, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the Gepotidacin GEP 10 µg?

Liofilchem, Inc., based in Waltham, MA, is the applicant of record for K261853.

How long did the K261853 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 23, 2026, 50 days later.

← All decisions in July 2026

Sources