NZA — Accessories, Germicide, Cleaning, For Endoscopes Class II
FDA product code NZA covers "Accessories, Germicide, Cleaning, For Endoscopes", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NZA
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232918 | steris corporation | enspire 300 Series Automated Endoscope Reprocessor | October 3, 2023 |
| K230560 | steris corporation | enspire 300 Series Automated Endoscope Reprocessor System | July 21, 2023 |
| K220361 | steris corporation | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | March 10, 2022 |
| K203223 | steris | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | January 28, 2021 |
| K200989 | steris corporation | Reliance Endoscope Processing System | May 14, 2020 |
| K123768 | steris corporation | RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM | July 26, 2013 |
| K110453 | steris corporation | RELIANCE ENDOSCOPE PROCESSING SYSTEM | March 16, 2011 |
| K102244 | steris corporation | RELIANCE ENDOSCOPE PROCESSING SYSTEM | December 3, 2010 |
| K040049 | steris corporation | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM | December 17, 2004 |
| K860704 | keymed | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | June 17, 1986 |
| K841331 | keymed | OLYMPUS KC-10 MOBILE DISINFEC-STAT | July 19, 1984 |