FDA Product Code NLQ: Single-use Reprocessed Ultrasonic Surgical Instruments

FDA product code NLQ covers single-use reprocessed ultrasonic surgical instruments cleared for use after validated reprocessing of originally single-use devices.

Ultrasonic surgical instruments are expensive; reprocessing provides a validated, cost-effective alternative that must meet the same safety and functional requirements as the original single-use device, including sterility, functionality, and absence of patient safety risks from reuse.

NLQ devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Sterilmed, Inc., Stryker Sustainability Solutions and Alliance Medical Corp..