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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 / April 2026 / K260696

510(k) cleared

MTS Gepotidacin 0.016-256 µg/mL

Liofilchem s.r.l. · Apr 17, 2026 · K260696

FDA cleared the MTS Gepotidacin 0.016-256 µg/mL from Liofilchem s.r.l. on Apr 17, 2026 under K260696, a traditional 510(k). The device falls under product code JWY, Manual Antimicrobial Susceptibility Test Systems, regulated at 21 CFR 866.1640 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 3, 2026. The decision came 45 days later, inside the 90 FDA-day goal for a 510(k).

Liofilchem s.r.l. has 2 other decisions in the tracker over the last 12 months: K261853 (Gepotidacin GEP 10 µg), K252114 (MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL).

Questions & Answers

What did FDA clear under K260696?

K260696 is the FDA 510(k) for MTS Gepotidacin 0.016-256 µg/mL, submitted by Liofilchem s.r.l.. FDA's decision date was Apr 17, 2026, under product code JWY (Manual Antimicrobial Susceptibility Test Systems).

Who makes the MTS Gepotidacin 0.016-256 µg/mL?

Liofilchem s.r.l., based in Roseto Degli Abruzzi, is the applicant of record for K260696.

How long did the K260696 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Apr 17, 2026, 45 days later.

← All decisions in April 2026

Sources