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FDA 510(k)

Foundation皮膚基質再生支架 Plus (DRS+) 獨立版

K 號：K243181 · 2024-10-31

申請人Bionova Medical, Inc.
決定日期2024-10-31
產品代碼FRO
決定相當於

器材摘要

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K243181. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K243181.

When did Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo receive FDA 510(k) clearance?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo received FDA 510(k) clearance on 2024-10-31, under 510(k) number K243181.

Who is the listed applicant for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

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

What is the FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo?

The FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo is FRO. This falls under the Anesthesiology category.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Bionova Medical, 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。

K240298Foundation皮膚基質再生支架 Plus (DRS+) 雙效版K231937Foundation 皮膚再生支架 (DRS) SoloK210949Foundation 皮膚再生支架 (DRS) Solo

相關器械（代碼：FRO）

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbHK254041皮膚智選抗菌濕凝膠Magic Science Supply, LLCK261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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