K241285 is an FDA 510(k) clearance for the Disposable Endoscope Valves Set (AF series). This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 1, 2024, 147 days after receiving the submission on May 7, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K241285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2024 |
| Decision Date | October 01, 2024 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC - Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |