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 / October 2025 / K250107

510(k) cleared

V-soft Line Barbed Surgical Suture (Various)

Feeltech Co., Ltd. · Oct 15, 2025 · K250107

FDA cleared the V-soft Line Barbed Surgical Suture (Various) from Feeltech Co., Ltd. on Oct 15, 2025 under K250107, 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 Jan 15, 2025. The decision came 273 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: K251414 (Miracu Polydioxanone (PDO) Suture and Needle (MONO)).

Questions & Answers

What did FDA clear under K250107?

K250107 is the FDA 510(k) for V-soft Line Barbed Surgical Suture (Various), submitted by Feeltech Co., Ltd.. FDA's decision date was Oct 15, 2025, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the V-soft Line Barbed Surgical Suture (Various)?

Feeltech Co., Ltd., based in Gunsan-Si, is the applicant of record for K250107.

How long did the K250107 review take?

FDA received the submission on Jan 15, 2025 and issued its decision on Oct 15, 2025, 273 days later.

← All decisions in October 2025

Sources