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FDA 510(k)

Natrelle 133S 組織擴張器

K 號：K254126 · 2026-01-16

申請人AbbVie
決定日期2026-01-16
產品代碼LCJ
決定相當於

器材摘要

Natrelle 133S Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is AbbVie. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K254126. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常見問題

What is the Natrelle 133S Tissue Expanders?

Natrelle 133S Tissue Expanders is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is AbbVie. The 510(k) number is K254126.

When did Natrelle 133S Tissue Expanders receive FDA 510(k) clearance?

Natrelle 133S Tissue Expanders received FDA 510(k) clearance on 2026-01-16, under 510(k) number K254126.

Who is the listed applicant for Natrelle 133S Tissue Expanders?

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

What is the FDA product code for Natrelle 133S Tissue Expanders?

The FDA product code for Natrelle 133S Tissue Expanders is LCJ.

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

相關器械（代碼：LCJ）

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。

K242963MENTOR™ PliaForm™ 乳房組織擴張器 配可縫針摺片Mentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLCK211676Motiva Flora 平滑絲質組織擴張器Motiva USA, LLCK214124AlloX2 Pro組織擴張器Sientra, Inc.K221127Sientra, Inc. PortfinderSientra, Inc.

官方來源

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