WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K253987

510(k) cleared

BARE Wireguided Balloon Dilation Catheter (1235)

GIE Medical · Mar 13, 2026 · K253987

FDA cleared the BARE Wireguided Balloon Dilation Catheter (1235) from GIE Medical on Mar 13, 2026 under K253987, a traditional 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 12, 2025. The decision came 91 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 GIE Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253987?

K253987 is the FDA 510(k) for BARE Wireguided Balloon Dilation Catheter (1235), submitted by GIE Medical. FDA's decision date was Mar 13, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the BARE Wireguided Balloon Dilation Catheter (1235)?

GIE Medical, based in Brooklyn Park, MN, is the applicant of record for K253987.

How long did the K253987 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Mar 13, 2026, 91 days later.

← All decisions in March 2026