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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 / January 2026 / K252957

510(k) cleared

Pneumo Dissector Hook

Ab Medica Sas · Jan 23, 2026 · K252957

FDA cleared the Pneumo Dissector Hook from Ab Medica Sas on Jan 23, 2026 under K252957, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 16, 2025. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ab Medica Sas in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252957?

K252957 is the FDA 510(k) for Pneumo Dissector Hook, submitted by Ab Medica Sas. FDA's decision date was Jan 23, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Pneumo Dissector Hook?

Ab Medica Sas, based in Centre-Val De Loire, is the applicant of record for K252957.

How long did the K252957 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Jan 23, 2026, 129 days later.

← All decisions in January 2026