NZAClass II

Accessories, Germicide, Cleaning, For Endoscopes

21 CFR 876.1500 / Gastroenterology, Urology

NZA is the FDA product code for Accessories, Germicide, Cleaning, For Endoscopes, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2023-10-03, and one recall.

Classification record

Product code: NZA
Device name: Accessories, Germicide, Cleaning, For Endoscopes
FDA 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).
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 1

Clearances, product code NZA

By decision year

11 clearances under product code NZA with a decision year between 1984 and 2023, 2023 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NZA by decision year
Year	Clearances
1984	1
1986	1
2004	1
2010	1
2011	1
2013	1
2020	1
2021	1
2022	1
2023	2

Applicants with the most clearances

Product code NZA

Applicants holding the most 510(k) clearances under product code NZA
Applicant	Clearances
STERIS Corporation	9
Keymed, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code