K211021 is an FDA 510(k) clearance for the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Micro-Tech (Nanjing) Co., Ltd. (Narijing, CN). The FDA issued a Cleared decision on May 6, 2022, 396 days after receiving the submission on April 5, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K211021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 396 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |