FDA 510(k)

GalaFLEX LITE 床架

K 號：K233999 · 2024-04-09

決定日期2024-04-09

產品代碼OOD

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

GalaFLEX LITE Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2024-04-09 under 510(k) number K233999. The device is classified under product code OOD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GalaFLEX LITE Scaffold?

GalaFLEX LITE Scaffold is a medical device that received FDA 510(k) clearance on 2024-04-09. The listed applicant is Tepha, Inc.. The 510(k) number is K233999.

When did GalaFLEX LITE Scaffold receive FDA 510(k) clearance?

GalaFLEX LITE Scaffold received FDA 510(k) clearance on 2024-04-09, under 510(k) number K233999.

Who is the listed applicant for GalaFLEX LITE Scaffold?

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

What is the FDA product code for GalaFLEX LITE Scaffold?

The FDA product code for GalaFLEX LITE Scaffold is OOD.

其他以 Tepha, 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。

K202425SurgiLattice 床架 K211307GalaSTITCH 可吸收單絲縫線 K162922GalaFORM 3D K161092GalaSHAPE 3D

相關器械（代碼：OOD）

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。

K202425SurgiLattice 床架Tepha, Inc.K162922GalaFORM 3DTepha, Inc.K161424Phasix 網格C.R. Bard, Inc.K161092GalaSHAPE 3DTepha, Inc.

官方來源

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