K200173 is an FDA 510(k) clearance for the Stone Retrieval Balloon. 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 Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 1, 2020, 99 days after receiving the submission on January 23, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K200173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2020 |
| Decision Date | May 01, 2020 |
| Days to Decision | 99 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 |