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 Stryker Sustainability Solutions.
FDA 510(k) Cleared Single-use Reprocessed Ultrasonic Surgical Instruments Devices (Product Code NLQ)
About Product Code NLQ - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code NLQ since 2001, with 27 receiving FDA clearance (average review time: 171 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NLQ have taken an average of 86 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
NLQ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →