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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 / December 2025 / K253888

510(k) cleared

MOLLI 2 System

Stryker Endoscopy · Dec 31, 2025 · K253888

FDA cleared the MOLLI 2 System from Stryker Endoscopy on Dec 31, 2025 under K253888, a special 510(k). The device falls under product code NEU, Marker, Radiographic, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 4, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Stryker Endoscopy has 7 other decisions in the tracker over the last 12 months: K262369 (AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down), DEN250040 (SportSuite Vision Software), K253602 (Precision S 4K Sinuscope), K261037 (780 nm SPY Portable Handheld Imaging (SPY-PHI) System).

Questions & Answers

What did FDA clear under K253888?

K253888 is the FDA 510(k) for MOLLI 2 System, submitted by Stryker Endoscopy. FDA's decision date was Dec 31, 2025, under product code NEU (Marker, Radiographic, Implantable).

Who makes the MOLLI 2 System?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K253888.

How long did the K253888 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Dec 31, 2025, 27 days later.

← All decisions in December 2025