FDA 510(k)

TP Pivot Pro™ 穿刺導引器

K 號：K233109 · 2023-12-22

決定日期2023-12-22

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

TP Pivot Pro™ Needle Guide is the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Solutions. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233109. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TP Pivot Pro™ Needle Guide?

TP Pivot Pro™ Needle Guide is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Civco Medical Solutions. The 510(k) number is K233109.

When did TP Pivot Pro™ Needle Guide receive FDA 510(k) clearance?

TP Pivot Pro™ Needle Guide received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233109.

Who is the listed applicant for TP Pivot Pro™ Needle Guide?

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

What is the FDA product code for TP Pivot Pro™ Needle Guide?

The FDA product code for TP Pivot Pro™ Needle Guide is ITX.

其他以 Civco Medical Solutions 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。

K190802想像式超音波墊及蓋

相關器械（代碼：ITX）

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。

K260114Align® 覆蓋及墊材導引工具CIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH 靜脈式超音波探頭帶EM-TECH Solutions, Inc.K260161SmartGuide 一次性導向器和網格UC-CARE , Ltd.K262474ND針導引系統Accurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

官方來源

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