Caldera Medical Gains 510(k) Clearance for Urinary Incontinence Device

Caldera Medical has received 510(k) marketing clearance from the FDA for its Desara TVez device for treatment of urinary incontinence in women.

The latest addition to the company’s Desara product range, the device features an 85-degree curve that closely contours the pubic bone and is available in diameters of 2.7 and 3.0 millimeters.

The Los Angeles-based company, which develops surgical products to treat urinary stress incontinence, pelvic organ prolapse and polyps, has an active humanitarian program and is committed to treating 1 million women in underserved populations around the world by 2025.