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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 / October 2025 / K251832

510(k) cleared

InZone IST Detachment System; IZDS Connecting Cable

Stryker Neurovascular · Oct 17, 2025 · K251832

FDA cleared the InZone IST Detachment System; IZDS Connecting Cable from Stryker Neurovascular on Oct 17, 2025 under K251832, a special 510(k). The device falls under product code HCG, Device, Neurovascular Embolization, regulated at 21 CFR 882.5950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 16, 2025. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Neurovascular has 3 other decisions in the tracker over the last 12 months: K261889 (Trevo Trak 21 Microcatheter), K253032 (AXS Lift Intracranial Base Catheter), K252694 (Target Detachable Coil).

Questions & Answers

What did FDA clear under K251832?

K251832 is the FDA 510(k) for InZone IST Detachment System; IZDS Connecting Cable, submitted by Stryker Neurovascular. FDA's decision date was Oct 17, 2025, under product code HCG (Device, Neurovascular Embolization).

Who makes the InZone IST Detachment System; IZDS Connecting Cable?

Stryker Neurovascular, based in Fremont, CA, is the applicant of record for K251832.

How long did the K251832 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Oct 17, 2025, 123 days later.

← All decisions in October 2025

Sources