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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 / October 2025 / K253125

510(k) cleared

Parietene Flat Sheet Mesh

Medtronic - Sofradim Production · Oct 24, 2025 · K253125

FDA cleared the Parietene Flat Sheet Mesh from Medtronic - Sofradim Production on Oct 24, 2025 under K253125, a special 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 Sep 25, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medtronic - Sofradim Production in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253125?

K253125 is the FDA 510(k) for Parietene Flat Sheet Mesh, submitted by Medtronic - Sofradim Production. FDA's decision date was Oct 24, 2025, under product code FTL (Mesh, Surgical, Polymeric).

Who makes the Parietene Flat Sheet Mesh?

Medtronic - Sofradim Production, based in Trévoux, is the applicant of record for K253125.

How long did the K253125 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Oct 24, 2025, 29 days later.

← All decisions in October 2025