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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 / K253530

510(k) cleared

Trexon Monofilament Synthetic Absorbable Suture

Medtronic · May 28, 2026 · K253530

FDA cleared the Trexon Monofilament Synthetic Absorbable Suture from Medtronic on May 28, 2026 under K253530, a traditional 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 13, 2025. The decision came 196 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic has 8 other decisions in the tracker over the last 12 months: K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K260195 (Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae), K253203 (Retrograde Coronary Sinus Perfusion Cannulae).

Questions & Answers

What did FDA clear under K253530?

K253530 is the FDA 510(k) for Trexon Monofilament Synthetic Absorbable Suture, submitted by Medtronic. FDA's decision date was May 28, 2026, under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Who makes the Trexon Monofilament Synthetic Absorbable Suture?

Medtronic, based in North Haven, CT, is the applicant of record for K253530.

How long did the K253530 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on May 28, 2026, 196 days later.

← All decisions in May 2026