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FDA 510(k)

Advanced Tissue Resection Device

K-Number: K251692 · 2026-02-21

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2026-02-21
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Advanced Tissue Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-02-21 under 510(k) number K251692. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced Tissue Resection Device?

Advanced Tissue Resection Device is a medical device that received FDA 510(k) clearance on 2026-02-21. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K251692.

When did Advanced Tissue Resection Device receive FDA 510(k) clearance?

Advanced Tissue Resection Device received FDA 510(k) clearance on 2026-02-21, under 510(k) number K251692.

Who is the listed applicant for Advanced Tissue Resection Device?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Tissue Resection Device?

The FDA product code for Advanced Tissue Resection Device is FDI.

Related Clinical Trials

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NCT06661525Monitoring Free Tissue Transfer Hemodynamics Using NIRSENROLLING_BY_INVITATIONNCT07238894A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer PatientsRECRUITINGNCT07274657Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) MalignancyRECRUITING

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252492Visualized Access and Delivery Catheter; PB Digital ControllerK250229Dual Action Tissue Closure DeviceK243388Disposable Distal CapK243471Extraction BasketK230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatibleK221784Single-use Video Pancreaticobiliary Scope, PB Digital Controller

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Related Devices (Code: FDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.K213222Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd.K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)STERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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