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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 / December 2025 / K250314

510(k) cleared

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

Surgical Instrument Service and Savings, Inc. · Dec 19, 2025 · K250314

FDA cleared the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer from Surgical Instrument Service and Savings, Inc. on Dec 19, 2025 under K250314, a traditional 510(k). The device falls under product code PNE, Reprocessed Catheter Introducer, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 4, 2025. The decision came 318 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Surgical Instrument Service and Savings, Inc. has one other decision in the tracker over the last 12 months: K252405 (Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter).

Questions & Answers

What did FDA clear under K250314?

K250314 is the FDA 510(k) for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer, submitted by Surgical Instrument Service and Savings, Inc.. FDA's decision date was Dec 19, 2025, under product code PNE (Reprocessed Catheter Introducer).

Who makes the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

Surgical Instrument Service and Savings, Inc., based in Redmond, OR, is the applicant of record for K250314.

How long did the K250314 review take?

FDA received the submission on Feb 4, 2025 and issued its decision on Dec 19, 2025, 318 days later.

← All decisions in December 2025

Sources