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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 / K260992

510(k) cleared

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

Neuralytix · Jun 25, 2026 · K260992

FDA cleared the iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) from Neuralytix on Jun 25, 2026 under K260992, a traditional 510(k). The device falls under product code PDQ, Neurosurgical Nerve Locator, regulated at 21 CFR 874.1820 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Mar 26, 2026. The decision came 91 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 Neuralytix in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260992?

K260992 is the FDA 510(k) for iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007), submitted by Neuralytix. FDA's decision date was Jun 25, 2026, under product code PDQ (Neurosurgical Nerve Locator).

Who makes the iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)?

Neuralytix, based in Fruita, CO, is the applicant of record for K260992.

How long did the K260992 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Jun 25, 2026, 91 days later.

← All decisions in June 2026