NZA

Accessories, Germicide, Cleaning, For Endoscopes

Product code
NZA
Device name
Accessories, Germicide, Cleaning, For Endoscopes
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
11 (all years; only the last 3 years are listed here)

FDA classification definition

High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-03.

NumberDecision dateApplicantDevice nameSummary
K2329182023-10-03STERIS Corporationenspire 300 Series Automated Endoscope ReprocessorPDF

1 summaries are archived here for direct download.

Official FDA classification page: NZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).