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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 / K261492

510(k) cleared

FieldFlex Steerable Sheath

CenterPoint Systems, LLC · Jun 5, 2026 · K261492

FDA cleared the FieldFlex Steerable Sheath from CenterPoint Systems, LLC on Jun 5, 2026 under K261492, a special 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 6, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

CenterPoint Systems, LLC has 4 other decisions in the tracker over the last 12 months: K261766 (CPS Locator 3D Plus Delivery Catheter), K262240 (SSPC NXT Delivery Catheter), K260942 (AuST Steerable Sheath), K260163 (AuST CSP Introducer).

Questions & Answers

What did FDA clear under K261492?

K261492 is the FDA 510(k) for FieldFlex Steerable Sheath, submitted by CenterPoint Systems, LLC. FDA's decision date was Jun 5, 2026, under product code DYB (Introducer, Catheter).

Who makes the FieldFlex Steerable Sheath?

CenterPoint Systems, LLC, based in West Valley City, UT, is the applicant of record for K261492.

How long did the K261492 review take?

FDA received the submission on May 6, 2026 and issued its decision on Jun 5, 2026, 30 days later.

← All decisions in June 2026

Sources