K243433 is an FDA 510(k) clearance for the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System. This device is classified as a Accessories, Cleaning, For Endoscope (Class II - Special Controls, product code FEB).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 2, 2024, 27 days after receiving the submission on November 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.1500. 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 | K243433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2024 |
| Decision Date | December 02, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FEB — Accessories, Cleaning, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | 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). |