NZA — Accessories, Germicide, Cleaning, For Endoscopes Class II
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 |