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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 / May 2026 / K253956

510(k) cleared

ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Sofradim Production · May 21, 2026 · K253956

FDA cleared the ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) from Sofradim Production on May 21, 2026 under K253956, a traditional 510(k). The device falls under product code FTL, Mesh, Surgical, Polymeric, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 10, 2025. The decision came 162 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 Sofradim Production in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253956?

K253956 is the FDA 510(k) for ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), submitted by Sofradim Production. FDA's decision date was May 21, 2026, under product code FTL (Mesh, Surgical, Polymeric).

Who makes the ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

Sofradim Production, based in Trévoux, is the applicant of record for K253956.

How long did the K253956 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on May 21, 2026, 162 days later.

← All decisions in May 2026