K203223 is an FDA 510(k) clearance for the Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide. This device is classified as a Accessories, Germicide, Cleaning, For Endoscopes (Class II - Special Controls, product code NZA).
Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on January 28, 2021, 87 days after receiving the submission on November 2, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.1500. 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) Number | K203223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | January 28, 2021 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NZA — Accessories, Germicide, Cleaning, For Endoscopes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| 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). |