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 / July 2026 / K253667

510(k) cleared

Accoat Guide Wire

Sp Medical A/S · Jul 14, 2026 · K253667

FDA cleared the Accoat Guide Wire from Sp Medical A/S on Jul 14, 2026 under K253667, a traditional 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 21, 2025. The decision came 235 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sp Medical A/S has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield), K253802 (KHEIRON® Spinal Fixation System, including patient specific K-ROD).

Questions & Answers

What did FDA clear under K253667?

K253667 is the FDA 510(k) for Accoat Guide Wire, submitted by Sp Medical A/S. FDA's decision date was Jul 14, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Accoat Guide Wire?

Sp Medical A/S, based in Karise, is the applicant of record for K253667.

How long did the K253667 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jul 14, 2026, 235 days later.

← All decisions in July 2026