K242845 is an FDA 510(k) clearance for the EGIS Biliary Double Bare Stent (BDB080405). This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by S&G Biotech, Inc. (Yongin-Si, KR). The FDA issued a Cleared decision on June 25, 2025, 278 days after receiving the submission on September 20, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K242845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | September 20, 2024 |
| Decision Date | June 25, 2025 |
| Days to Decision | 278 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 |