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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 / November 2025 / K252592

510(k) cleared

TELLTALE Electrosurgical Guidewire System

Telltale, LLC · Nov 13, 2025 · K252592

FDA cleared the TELLTALE Electrosurgical Guidewire System from Telltale, LLC on Nov 13, 2025 under K252592, a traditional 510(k). The device falls under product code SGO, Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures, regulated at 21 CFR 870.1254 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 15, 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 Telltale, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252592?

K252592 is the FDA 510(k) for TELLTALE Electrosurgical Guidewire System, submitted by Telltale, LLC. FDA's decision date was Nov 13, 2025, under product code SGO (Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures).

Who makes the TELLTALE Electrosurgical Guidewire System?

Telltale, LLC, based in Andover, MA, is the applicant of record for K252592.

How long did the K252592 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Nov 13, 2025, 90 days later.

← All decisions in November 2025