WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K254275

510(k) cleared

HyperSuture All Green Extension Line

Threadstone, LLC · Mar 23, 2026 · K254275

FDA cleared the HyperSuture All Green Extension Line from Threadstone, LLC on Mar 23, 2026 under K254275, a traditional 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 30, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Threadstone, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254275?

K254275 is the FDA 510(k) for HyperSuture All Green Extension Line, submitted by Threadstone, LLC. FDA's decision date was Mar 23, 2026, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the HyperSuture All Green Extension Line?

Threadstone, LLC, based in Millersville, MD, is the applicant of record for K254275.

How long did the K254275 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Mar 23, 2026, 83 days later.

← All decisions in March 2026