Advanced Tissue Resection Device
FDA 510(k) K251692 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK251692
Submission
- Device name
- Advanced Tissue Resection Device
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- June 2, 2025
- Decision date
- February 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital ControllerSHU · Traditional | 04/24/2026SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | 09/08/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | 06/27/2025SE |
| K243471 | Extraction BasketLQR · Traditional | 12/16/2024SE |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…FGE · Traditional | 09/06/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | 02/16/2023SE |
| K222354 | Elastic Traction SystemQSW · Traditional | 10/03/2022SE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…KTI · Traditional | 07/20/2022SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | 07/08/2022SE |
| K220157 | Disposable Hemostatic Closure Clip DevicePKL · Traditional | 06/13/2022SE |
Questions and answers
When was Advanced Tissue Resection Device cleared by the FDA?
Advanced Tissue Resection Device (K251692) received a 510(k) decision of Substantially Equivalent on February 21, 2026, 264 days after the submission was received.
What is the product code of K251692?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.