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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 / K252051

510(k) cleared

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

Tulavi Therapeutics, Inc. · Sep 29, 2025 · K252051

FDA cleared the allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) from Tulavi Therapeutics, Inc. on Sep 29, 2025 under K252051, a traditional 510(k). The device falls under product code SBG, In Situ Polymerizing Peripheral Nerve Cap, regulated at 21 CFR 882.5260 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 1, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252051?

K252051 is the FDA 510(k) for allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627), submitted by Tulavi Therapeutics, Inc.. FDA's decision date was Sep 29, 2025, under product code SBG (In Situ Polymerizing Peripheral Nerve Cap).

Who makes the allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)?

Tulavi Therapeutics, Inc., based in Los Gatos, CA, is the applicant of record for K252051.

How long did the K252051 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Sep 29, 2025, 90 days later.

← All decisions in September 2025