K181472 is an FDA 510(k) clearance for the AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor. This device is classified as a Accessories, Cleaning, For Endoscope (Class II - Special Controls, product code FEB).
Submitted by Advanced Sterilization Products (Asp) (Irvin, US). The FDA issued a Cleared decision on April 23, 2019, 323 days after receiving the submission on June 4, 2018.
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 | K181472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | April 23, 2019 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| 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). |