FDA 510(k)

先進組織切除設備

K 號：K251692 · 2026-02-21

決定日期2026-02-21

產品代碼FDI

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Micro-Tech (Nanjing) Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252492視覺化進入與輸送導管；PB數位控制器 K250229雙動力組織閉合設備 K243388一次性遠端帽 K243471抽獲籃 K230127膽管塑料支架、膽管塑料支架導入器、膽管塑料支架組、膽管塑料支架導入器/短針相容、膽管塑料支架組/短針相容 K221784單次使用視覺胰膽管內視鏡，PB數位控制器

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相關器械（代碼：FDI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221713多腸瘜肉圈Hangzhou AGS MedTech Co., Ltd.K220846核心-SNAREIncore Co., Ltd.K220089一次性多腫瘤圈套Jiangsu Vedkang Medical Science and Technology Co., Ltd.K220790一次性腫瘍切除圈，一次性腫瘍切除混合圈Yangzhou Fartley Medical Instrument Technology Co., Ltd.K213222一次性切除圈Beijing Zksk Technology Co., Ltd.K212860智能帶EMR套件（SB-EMR-K，SB-EMR-K-12，SB-EMR-K-9.4），智能帶EMR包裝（SB-EMR-P，SB-EMR-P-12，SB-EMR-P-9.4），SmartSnare EMR六邊形套索（SS-230-1或與套件搭配出貨）STERIS Corporation

官方來源

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