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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 / January 2026 / K253698

510(k) cleared

Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes

Cooper Surgical · Jan 20, 2026 · K253698

FDA cleared the Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes from Cooper Surgical on Jan 20, 2026 under K253698, a traditional 510(k). The device falls under product code HHW, Pessary, Vaginal, regulated at 21 CFR 884.3575 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 24, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cooper Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253698?

K253698 is the FDA 510(k) for Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes, submitted by Cooper Surgical. FDA's decision date was Jan 20, 2026, under product code HHW (Pessary, Vaginal).

Who makes the Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes?

Cooper Surgical, based in Trumbull, CT, is the applicant of record for K253698.

How long did the K253698 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 20, 2026, 57 days later.

← All decisions in January 2026