K251692 is an FDA 510(k) clearance for the Advanced Tissue Resection Device, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on February 21, 2026, 264 days after receiving the submission on June 2, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K251692 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 2025 |
| Decision Date | February 21, 2026 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |