K232918 is an FDA 510(k) clearance for the enspire 300 Series Automated Endoscope Reprocessor. This device is classified as a Accessories, Germicide, Cleaning, For Endoscopes (Class II - Special Controls, product code NZA).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 3, 2023, 14 days after receiving the submission on September 19, 2023.
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 | K232918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2023 |
| Decision Date | October 03, 2023 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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). |