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FDA 510(k)

REGENETEN™ 生物誘導植入體

K 號：K242631 · 2024-11-26

申請人Smith & Nephew Inc., Endoscopy Div.
決定日期2024-11-26
產品代碼OWY
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

REGENETEN™ Bioinductive Implant is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242631. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the REGENETEN™ Bioinductive Implant?

REGENETEN™ Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K242631.

When did REGENETEN™ Bioinductive Implant receive FDA 510(k) clearance?

REGENETEN™ Bioinductive Implant received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242631.

Who is the listed applicant for REGENETEN™ Bioinductive Implant?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENETEN™ Bioinductive Implant?

The FDA product code for REGENETEN™ Bioinductive Implant is OWY.

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。

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相關器械（代碼：OWY）

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。

K251690Arthrex SpeedFLEX™ 假體Arthrex, Inc.K252647織錦生物整合植入體Embody, Inc.K250109TYBR 膠原膠Tybr HealthK243843腱保護器（50242）Kerecis LimitedK222501再生生物導引式植入體Smith and Nephew, Inc.K220867織錦生物整合植入體Embody, Inc.

官方來源

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