K210660 is an FDA 510(k) clearance for the Stone Retrieval Balloon Catheter. This device is classified as a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II - Special Controls, product code GCA).
Submitted by Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 27, 2021, 54 days after receiving the submission on March 4, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K210660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2021 |
| Decision Date | April 27, 2021 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCA - Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |