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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 / K251170

510(k) cleared

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

Tangent Endoscopy, LLC · Sep 12, 2025 · K251170

FDA cleared the Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller from Tangent Endoscopy, LLC on Sep 12, 2025 under K251170, a traditional 510(k). The device falls under product code FBN, Choledochoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 15, 2025. The decision came 150 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 Tangent Endoscopy, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251170?

K251170 is the FDA 510(k) for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller, submitted by Tangent Endoscopy, LLC. FDA's decision date was Sep 12, 2025, under product code FBN (Choledochoscope And Accessories, Flexible/Rigid).

Who makes the Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?

Tangent Endoscopy, LLC, based in Camden, DE, is the applicant of record for K251170.

How long did the K251170 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Sep 12, 2025, 150 days later.

← All decisions in September 2025