FDA 510(k)

PELNAC 網狀雙層傷口組織

K 號：K213498 · 2022-07-14

決定日期2022-07-14

產品代碼KGN

決定相當於

器材摘要

PELNAC Meshed Bilayer Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gunze Limited. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K213498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the PELNAC Meshed Bilayer Wound Matrix?

PELNAC Meshed Bilayer Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Gunze Limited. The 510(k) number is K213498.

When did PELNAC Meshed Bilayer Wound Matrix receive FDA 510(k) clearance?

PELNAC Meshed Bilayer Wound Matrix received FDA 510(k) clearance on 2022-07-14, under 510(k) number K213498.

Who is the listed applicant for PELNAC Meshed Bilayer Wound Matrix?

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

What is the FDA product code for PELNAC Meshed Bilayer Wound Matrix?

The FDA product code for PELNAC Meshed Bilayer Wound Matrix is KGN.

其他以 Gunze 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。

K221487NEOVEIL 鋼釘線加固 K213573PELNAC 點綴傷口組織 K191992PELNAC雙層傷口組織

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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