K220884 is an FDA 510(k) clearance for the Disposable Endoscope Valve Sets. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Sml Med-Tech Solutions Limited (Fo Tan, N.T., CN). The FDA issued a Cleared decision on January 17, 2023, 295 days after receiving the submission on March 28, 2022.
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 | K220884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2022 |
| Decision Date | January 17, 2023 |
| Days to Decision | 295 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. |