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FDA 510(k)

Shiley™ 口腔/鼻腔氣管配TaperGuard™ 膨脹環加強，Murphy 眼 Shiley™ 氣管管 TaperGuard™ 膨脹環加強並帶針 Shiley™ 低曲線口腔/鼻腔氣管配氣管加強 Shiley™ 低曲線口腔/鼻腔氣管配氣管加強，Murphy 眼 Shiley™ 口腔/鼻腔氣管無氣管加強

K 號：K243785 · 2025-09-25

申請人Covidien, LLC
決定日期2025-09-25
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K243785. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced?

Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Covidien, LLC. The 510(k) number is K243785.

When did Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced receive FDA 510(k) clearance?

Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced received FDA 510(k) clearance on 2025-09-25, under 510(k) number K243785.

Who is the listed applicant for Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced?

FDA 510(k) 記錄將 Covidien, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced?

The FDA product code for Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced is BTR.

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

其他以 Covidien, LLC 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。

K261070LigaSure™ RAS 馬里蘭 頰部 血管 黏合器/分離器，納米塗層K253527Tri-Staple™ 2.0 黑色圓形重裝 21mm 過厚 (SIGCIR21XT)；Tri-Staple™ 2.0 黑色圓形重裝 25mm 過厚 (SIGCIR25XT)K253984觸術輔助™儀器之出氣點K253030Capnostream™35 輕便呼吸監測器 (PM35MN)K251025Mon-a-Therm™ 食管式聽診器配溫度感測器 400TM (90041, 90042, 90043, 90049)K251313Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，近端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，近端配用一次性內管；Shiley™成人柔軟一次性內管XLT

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相關器械（代碼：BTR）

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。

K251794Tenax® 適應激光內氣管管Bryan Medical, Inc.K253437斯匹羅-維斯塔Spiro RoboticsK250173Shiley™ 口腔RAE 氣管管無氣囊，墨菲眼（113-XX）Shiley™ 鼻腔RAE 氣管管無氣囊，墨菲眼（114-XX）Shiley™ 口腔RAE 氣管管有氣囊，墨菲眼（115-XX）Shiley™ 口腔RAE 氣管管配TaperGuard™ 氣囊，墨菲眼（115-XXOR）Shiley™ 鼻腔RAE 氣管管配TaperGuard™ 氣囊，墨菲眼（119-XXNR）Covidien, LLCK243579AeroJet 通氣導尿管Pipeline Medical Products, LLCK251499Frova 通氣導管引入器 (C-CAE-14.0-70-FII)；Frova 通氣導管引入器 (C-CAE-14.0-70-FI)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe ApsK250243ProVu單次使用視頻型針筒，配強化氣管內管（尺寸6.5）(038-995-065U)；ProVu單次使用視頻型針筒，配強化氣管內管（尺寸7.0）(038-995-070U)；ProVu單次使用視頻型針筒，配強化氣管內管（尺寸7.5）(038-995-075U)；ProVu單次使用視頻型針筒，配強化氣管內管（尺寸8.0）(038-995-080U)Flexicare Medical Limited.

官方來源

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