K202838 is an FDA 510(k) clearance for the Andorate Universal Endoscope Tip Guard. This device is classified as a Endoscopic Storage Cover (Class II - Special Controls, product code OCU).
Submitted by Ga Health Company Limited (Hong Kong, CN). The FDA issued a Cleared decision on March 5, 2021, 161 days after receiving the submission on September 25, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization..
| 510(k) Number | K202838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCU — Endoscopic Storage Cover |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization. |