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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 a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-02-21 under approval 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. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K251692.

When was Advanced Tissue Resection Device approved by the FDA?

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

What company makes Advanced Tissue Resection Device?

Advanced Tissue Resection Device is manufactured by Micro-Tech (Nanjing) Co., Ltd..

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

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

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Related PubMed Literature

PMID: 41832928 Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China. European radiology (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026)

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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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