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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 / June 2026 / K252171

510(k) cleared

Barbed PDO Suture

Sutura Medical Technology, Inc. · Jun 12, 2026 · K252171

FDA cleared the Barbed PDO Suture from Sutura Medical Technology, Inc. on Jun 12, 2026 under K252171, 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 Jul 10, 2025. The decision came 337 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sutura Medical Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252171?

K252171 is the FDA 510(k) for Barbed PDO Suture, submitted by Sutura Medical Technology, Inc.. FDA's decision date was Jun 12, 2026, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the Barbed PDO Suture?

Sutura Medical Technology, Inc., based in Dedham, MA, is the applicant of record for K252171.

How long did the K252171 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Jun 12, 2026, 337 days later.

← All decisions in June 2026