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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 / August 2026 / K262056

510(k) cleared

Rusch Latex Gold Foley Catheter

Teleflex Medical Sdn. Bhd. · Aug 5, 2026 · K262056

FDA cleared the Rusch Latex Gold Foley Catheter from Teleflex Medical Sdn. Bhd. on Aug 5, 2026 under K262056, a traditional 510(k). The device falls under product code EZL, Catheter, Retention Type, Balloon, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 18, 2026. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

Teleflex Medical Sdn. Bhd. has 2 other decisions in the tracker over the last 12 months: K252643 (Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled), K252537 (Rusch SoftSimplastic Foley Catheters).

Questions & Answers

What did FDA clear under K262056?

K262056 is the FDA 510(k) for Rusch Latex Gold Foley Catheter, submitted by Teleflex Medical Sdn. Bhd.. FDA's decision date was Aug 5, 2026, under product code EZL (Catheter, Retention Type, Balloon).

Who makes the Rusch Latex Gold Foley Catheter?

Teleflex Medical Sdn. Bhd., based in Kamunting, is the applicant of record for K262056.

How long did the K262056 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Aug 5, 2026, 48 days later.

← All decisions in August 2026

Sources