FDA 510(k)

多用途 PAL 管針及 PAL 手動棒

K 號：K171286 · 2017-10-13

決定日期2017-10-13

產品代碼QPB

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

PAL Multi-Use Cannulas and PAL Manual Wand is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K171286. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PAL Multi-Use Cannulas and PAL Manual Wand?

PAL Multi-Use Cannulas and PAL Manual Wand is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K171286.

When did PAL Multi-Use Cannulas and PAL Manual Wand receive FDA 510(k) clearance?

PAL Multi-Use Cannulas and PAL Manual Wand received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171286.

Who is the listed applicant for PAL Multi-Use Cannulas and PAL Manual Wand?

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

What is the FDA product code for PAL Multi-Use Cannulas and PAL Manual Wand?

The FDA product code for PAL Multi-Use Cannulas and PAL Manual Wand is QPB.

其他以 Microaire Surgical Instruments, 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。

K243589PAL 過濾殺菌盒 K244026PAL 7020 控制台 K242804PAL 吸引系統 K220318PAL 渗透系統 K212024PAL系統 K181819SMARTRELEASE內視鏡軟組織釋放系統

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相關器械（代碼：QPB）

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。

K254135脂脂手術藝術家NOUVAG AG K261710AYON™ Power Liposuction Cannulas 和 AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation K251944Lipocosm 和諧系統Lipocosm, LLC K253396AYON 身體雕塑系統™ (AYON SYSTEM)Apyx Medical Corporation K252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON 身體雕塑系統 (AYON SYSTEM)Apyx Medical Corporation

官方來源

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