FDA 510(k)

視覺化進入與輸送導管；PB數位控制器

K 號：K252492 · 2026-04-24

決定日期2026-04-24

產品代碼SHU

諮詢委員會GU

決定相當於

器材摘要

Visualized Access and Delivery Catheter; PB Digital Controller 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 2026-04-24 under 510(k) number K252492. The device is classified under product code SHU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Visualized Access and Delivery Catheter; PB Digital Controller?

Visualized Access and Delivery Catheter; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K252492.

When did Visualized Access and Delivery Catheter; PB Digital Controller receive FDA 510(k) clearance?

Visualized Access and Delivery Catheter; PB Digital Controller received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252492.

Who is the listed applicant for Visualized Access and Delivery Catheter; PB Digital Controller?

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 Visualized Access and Delivery Catheter; PB Digital Controller?

The FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller is SHU.

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

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K251692先進組織切除設備 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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器材摘要

常見問題

相關臨床試驗

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

官方來源