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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 / May 2026 / K253295

510(k) cleared

Coude Sleeved IC; Coude Plus Sleeved IC

Hollister Incorporated · May 18, 2026 · K253295

FDA cleared the Coude Sleeved IC; Coude Plus Sleeved IC from Hollister Incorporated on May 18, 2026 under K253295, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 29, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hollister Incorporated has one other decision in the tracker over the last 12 months: K251468 (Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)).

Questions & Answers

What did FDA clear under K253295?

K253295 is the FDA 510(k) for Coude Sleeved IC; Coude Plus Sleeved IC, submitted by Hollister Incorporated. FDA's decision date was May 18, 2026, under product code EZD (Catheter, Straight).

Who makes the Coude Sleeved IC; Coude Plus Sleeved IC?

Hollister Incorporated, based in Libertyville, IL, is the applicant of record for K253295.

How long did the K253295 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 18, 2026, 231 days later.

← All decisions in May 2026

Sources