NZA · Class II · 21 CFR 876.1500

FDA Product Code NZA: Accessories, Germicide, Cleaning, For Endoscopes

Endoscope reprocessing is critical to infection prevention in endoscopy units. FDA product code NZA covers germicide and cleaning accessories for endoscope reprocessing.

These products include enzymatic cleaners, high-level disinfectants, and automated endoscope reprocessor solutions used in the multi-step cleaning and disinfection cycle that renders flexible endoscopes safe for reuse between patients.

NZA devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA General Hospital panel.

Leading manufacturers include STERIS Corporation and Steris.

4
Total
4
Cleared
69d
Avg days
2021
Since

List of Accessories, Germicide, Cleaning, For Endoscopes devices cleared through 510(k)

4 devices
1–4 of 4

How to use this database

This page lists all FDA 510(k) submissions for Accessories, Germicide, Cleaning, For Endoscopes devices (product code NZA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →