FDA 510(k)

赫利俄斯皮膚支架

K 號：K250397 · 2025-08-15

決定日期2025-08-15

產品代碼KGN

決定相當於

器材摘要

Helios Dermal Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Helios Biomedical, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K250397. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Helios Dermal Scaffold?

Helios Dermal Scaffold is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Helios Biomedical, Inc.. The 510(k) number is K250397.

When did Helios Dermal Scaffold receive FDA 510(k) clearance?

Helios Dermal Scaffold received FDA 510(k) clearance on 2025-08-15, under 510(k) number K250397.

Who is the listed applicant for Helios Dermal Scaffold?

The FDA 510(k) record lists Helios Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helios Dermal Scaffold?

The FDA product code for Helios Dermal Scaffold is KGN.

其他以 Helios Biomedical, Inc. 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。

K250420赫利俄斯杜拉再生網格

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。