FDA 510(k)

InnovaBurn

K 號：K213716 · 2022-09-29

決定日期2022-09-29

產品代碼KGN

決定相當於

器材摘要

InnovaBurn is the device name listed in this FDA 510(k) record. The listed applicant is Triad Life Sciences, Inc.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K213716. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the InnovaBurn?

InnovaBurn is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Triad Life Sciences, Inc.. The 510(k) number is K213716.

When did InnovaBurn receive FDA 510(k) clearance?

InnovaBurn received FDA 510(k) clearance on 2022-09-29, under 510(k) number K213716.

Who is the listed applicant for InnovaBurn?

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

What is the FDA product code for InnovaBurn?

The FDA product code for InnovaBurn is KGN.

其他以 Triad Life Sciences, 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。

K211902InnovaMatrix PD K210580InnovaMatrix FS K193552InnovaMatrix

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。