FDA 510(k)

MENTOR™ PliaForm™ 乳房組織擴張器配可縫針摺片

K 號：K242963 · 2025-04-24

決定日期2025-04-24

產品代碼LCJ

決定相當於

器材摘要

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K242963. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常見問題

What is the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K242963.

When did MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs receive FDA 510(k) clearance?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242963.

Who is the listed applicant for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

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

What is the FDA product code for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

The FDA product code for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is LCJ.

其他以 Mentor Worldwide, LLC 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。

K243271MENTOR™記憶形態™可重消毒膠質乳房植入物尺寸計；MENTOR™記憶膠™可重消毒膠質乳房植入物尺寸計；MENTOR™記憶膠™單次使用膠質尺寸計 K243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器 K241552MENTOR™ 變形膠體增強單次使用膠體尺寸計 K241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器 K182335CPX 4 平滑表面乳房組織擴張器 K161176ARTOURA 平滑表面乳腺組織擴張器

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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。

K254126Natrelle 133S 組織擴張器AbbVie K243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLC K241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLC K211676Motiva Flora 平滑絲質組織擴張器Motiva USA, LLC K214124AlloX2 Pro組織擴張器Sientra, Inc.K221127Sientra, Inc. PortfinderSientra, Inc.

官方來源

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