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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 / April 2026 / K252943

510(k) cleared

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Convatec Limited · Apr 1, 2026 · K252943

FDA cleared the GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women from Convatec Limited on Apr 1, 2026 under K252943, 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 15, 2025. The decision came 198 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Convatec Limited has one other decision in the tracker over the last 12 months: K260737 (Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).).

Questions & Answers

What did FDA clear under K252943?

K252943 is the FDA 510(k) for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women, submitted by Convatec Limited. FDA's decision date was Apr 1, 2026, under product code EZD (Catheter, Straight).

Who makes the GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

Convatec Limited, based in Deeside, Flintshire, is the applicant of record for K252943.

How long did the K252943 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Apr 1, 2026, 198 days later.

← All decisions in April 2026

Sources