21 CFR 874.5550 — Irrigator, Powered Nasal

Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5550

Identification

A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KMAIrrigator, Powered Nasal15
Innolitics

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