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FDA 510(k)

Triopsy 驱動器 (TMSDGB)；Triopsy 結締針 (BN-1825-36-01)；Triopsy 結締針 (BN-1825-55-01)

K 號：K242228 · 2025-01-10

申請人Triopsy Medical, Inc.
決定日期2025-01-10
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) is the device name listed in this FDA 510(k) record. The listed applicant is Triopsy Medical, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K242228. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)?

Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Triopsy Medical, Inc.. The 510(k) number is K242228.

When did Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) receive FDA 510(k) clearance?

Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242228.

Who is the listed applicant for Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)?

The FDA 510(k) record lists Triopsy Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)?

The FDA product code for Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) is KNW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：KNW）

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。

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官方來源

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