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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 / April 2026 / K253580

510(k) cleared

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Tedan Surgical Innovations · Apr 26, 2026 · K253580

FDA cleared the Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) from Tedan Surgical Innovations on Apr 26, 2026 under K253580, 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 Nov 17, 2025. The decision came 160 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 Tedan Surgical Innovations in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253580?

K253580 is the FDA 510(k) for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S), submitted by Tedan Surgical Innovations. FDA's decision date was Apr 26, 2026, under product code PDQ (Neurosurgical Nerve Locator).

Who makes the Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

Tedan Surgical Innovations, based in Sugar Land, TX, is the applicant of record for K253580.

How long did the K253580 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 26, 2026, 160 days later.

← All decisions in April 2026