NZA
- 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).
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232918 | 2023-10-03 | STERIS Corporation | enspire 300 Series Automated Endoscope Reprocessor |
Official FDA classification page: NZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).