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.

11
Total
11
Cleared
112d
Avg days
1984
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Accessories, Germicide, Cleaning, For Endoscopes Devices (Product Code NZA)

11 devices
1–11 of 11
Cleared Oct 03, 2023
enspire 300 Series Automated Endoscope Reprocessor
K232918
STERIS Corporation
General Hospital · 14d
Cleared Jul 21, 2023
enspire 300 Series Automated Endoscope Reprocessor System
K230560
STERIS Corporation
General Hospital · 143d
Cleared Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361
STERIS Corporation
General Hospital · 30d
Cleared Jan 28, 2021
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223
Steris
General Hospital · 87d

About Product Code NZA - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code NZA since 1984, with 11 receiving FDA clearance (average review time: 112 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

NZA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →