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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 / K251414

510(k) cleared

Miracu Polydioxanone (PDO) Suture and Needle (MONO)

Feeltech Co., Ltd. · Oct 20, 2025 · K251414

FDA cleared the Miracu Polydioxanone (PDO) Suture and Needle (MONO) from Feeltech Co., Ltd. on Oct 20, 2025 under K251414, a traditional 510(k). The device falls under product code NEW, Suture, Surgical, Absorbable, Polydioxanone, regulated at 21 CFR 878.4840 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 7, 2025. The decision came 166 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Feeltech Co., Ltd. has one other decision in the tracker over the last 12 months: K250107 (V-soft Line Barbed Surgical Suture (Various)).

Questions & Answers

What did FDA clear under K251414?

K251414 is the FDA 510(k) for Miracu Polydioxanone (PDO) Suture and Needle (MONO), submitted by Feeltech Co., Ltd.. FDA's decision date was Oct 20, 2025, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the Miracu Polydioxanone (PDO) Suture and Needle (MONO)?

Feeltech Co., Ltd., based in Gunsan-Si, is the applicant of record for K251414.

How long did the K251414 review take?

FDA received the submission on May 7, 2025 and issued its decision on Oct 20, 2025, 166 days later.

← All decisions in October 2025

Sources