DeviceClearance

Product code QXM— Gastroenterology, Urology

Revi System

Classification name
Implanted Tibial Electrical Urinary Continence Device
Device class
Class 2
Regulation
21 CFR 876.5305
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

FDA classification definition

“An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.”

— U.S. Food and Drug Administration, device classification record for product code QXM under 21 CFR 876.5305, via openFDA

Market context for product code QXM

FDA has cleared 4 devices under product code QXM between 2023 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QXM

Recent clearances under product code QXM

Data sourced from openFDA. This site is unofficial and independent of the FDA.