K102244 is an FDA 510(k) clearance for the RELIANCE ENDOSCOPE PROCESSING SYSTEM. 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 December 3, 2010, 116 days after receiving the submission on August 9, 2010.
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 | K102244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2010 |
| Decision Date | December 03, 2010 |
| Days to Decision | 116 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). |