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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 / September 2025 / K252227

510(k) cleared

Pounce(TM) Sheath

Surmodics,Inc. · Sep 24, 2025 · K252227

FDA cleared the Pounce(TM) Sheath from Surmodics,Inc. on Sep 24, 2025 under K252227, 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 Jul 16, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252227?

K252227 is the FDA 510(k) for Pounce(TM) Sheath, submitted by Surmodics,Inc.. FDA's decision date was Sep 24, 2025, under product code DYB (Introducer, Catheter).

Who makes the Pounce(TM) Sheath?

Surmodics,Inc., based in Eden Prairie, MN, is the applicant of record for K252227.

How long did the K252227 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Sep 24, 2025, 70 days later.

← All decisions in September 2025