FDA 510(k)

BIOBRANE 暫時性傷口敷料；BIOBRANE 手套

K 號：K242146 · 2024-12-17

決定日期2024-12-17

產品代碼KGN

決定相當於

器材摘要

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K242146. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K242146.

When did BIOBRANE Temporary Wound Dressing; BIOBRANE Glove receive FDA 510(k) clearance?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242146.

Who is the listed applicant for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

The FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is KGN.

其他以 Smith & Nephew Medical Limited 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。

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相關器械（代碼：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.

官方來源

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