Bionix Development Corporation

Device typeEar canal lavage system: A device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.

FDA categoryAPPLICATOR, ENT DRUG

Device ID00859911004146

Catalog number7280

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information