K251229 is an FDA 510(k) clearance for the EndoFix?Tissue Fixation System, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Softac Medical Technologies (Plainville, US). The FDA issued a Cleared decision on August 20, 2025, 121 days after receiving the submission on April 21, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K251229 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 21, 2025 |
| Decision Date | August 20, 2025 |
| Days to Decision | 121 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 |