Advanced Tissue Resection Device— 510(k) K251692
Substantially EquivalentMicro-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K251692 for Advanced Tissue Resection Device, Substantially Equivalent on 2026-02-21. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.
Summary
Micro-Tech (Nanjing) filed the Advanced Tissue Resection Device under product code FDI, flexible snare. The name is generic, and the record doesn't describe the device further.
Class II, 21 CFR 876.4300. Gastroenterology, Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Micro-Tech (Nanjing) filed from Nanjing, China. FDA found it substantially equivalent 264 calendar days after receipt (June 2, 2025 to February 21, 2026).
Clearance details
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Product code
- Product code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code FDI
view allMore clearances from Micro-Tech (Nanjing) Co., Ltd.
view allAdverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.