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FDA 510(k)

FiberStitch 嵌入式醫療設備，曲型帶兩個聚酯嵌入式設備及 2-0 FiberWire，FiberStitch 嵌入式醫療設備，直型帶兩個聚酯嵌入式設備及 2-0 FiberWire

K 號：K221731 · 2022-09-07

申請人T.A.G. Medical Products Corporation, Ltd.
決定日期2022-09-07
產品代碼MBI
諮詢委員會或
決定相當於

器材摘要

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K221731. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K221731.

When did FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire receive FDA 510(k) clearance?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire received FDA 510(k) clearance on 2022-09-07, under 510(k) number K221731.

Who is the listed applicant for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

FDA 510(k) 記錄將 T.A.G. 医療產品股份有限公司有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

The FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is MBI.

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 T.A.G. Medical Products Corporation, 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。

K253858GFS - 無菌螺釘及帽子K231400無刀針 Trocar – 阿瑞斯 Lap 穿刺針K230058無刀針 Trocar – 阿瑞斯 Lap 穿刺針K210498貝塔連結無縫植入系統K202178VersaLoop 牽引系統K190125FiberStitch 嵌入式醫療設備，曲型帶兩個聚酯嵌入式設備及 2-0 FiberWire，FiberStitch 嵌入式醫療設備，直型帶兩個聚酯嵌入式設備及 2-0 FiberWire

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相關器械（代碼：MBI）

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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