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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 / K252405

510(k) cleared

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Surgical Instrument Service and Savings, Inc. · Nov 26, 2025 · K252405

FDA cleared the Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter from Surgical Instrument Service and Savings, Inc. on Nov 26, 2025 under K252405, a traditional 510(k). The device falls under product code NLH, Catheter, Recording, Electrode, Reprocessed, regulated at 21 CFR 870.1220 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 31, 2025. The decision came 118 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: K250314 (Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer).

Questions & Answers

What did FDA clear under K252405?

K252405 is the FDA 510(k) for Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter, submitted by Surgical Instrument Service and Savings, Inc.. FDA's decision date was Nov 26, 2025, under product code NLH (Catheter, Recording, Electrode, Reprocessed).

Who makes the Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter?

Surgical Instrument Service and Savings, Inc., based in Redmond, OR, is the applicant of record for K252405.

How long did the K252405 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Nov 26, 2025, 118 days later.

← All decisions in November 2025

Sources