FDA 510(k)

SurgiCount+ 系統

K 號：K232250 · 2024-01-11

決定日期2024-01-11

產品代碼PBZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

SurgiCount+ System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K232250. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SurgiCount+ System?

SurgiCount+ System is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Stryker Instruments. The 510(k) number is K232250.

When did SurgiCount+ System receive FDA 510(k) clearance?

SurgiCount+ System received FDA 510(k) clearance on 2024-01-11, under 510(k) number K232250.

Who is the listed applicant for SurgiCount+ System?

FDA 510(k) 記錄將 Stryker Instruments 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SurgiCount+ System?

The FDA product code for SurgiCount+ System is PBZ.

其他以 Stryker Instruments 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。

K261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）K261544水灌系統 K253679水灌系統 K252282SurgiCount+ 系統 K251971RPS 主要全膝关节置换軟體；RPS 控制台；RPS 鋸 One；RPS 線材；RPS 鋸振動針筒；RPS 控制台車輛附件；球頭指針 K250483PhotonBlade 3；PhotonBlade 3煙霧抽離器

查看所有 21 項裝置 →

相關器械（代碼：PBZ）

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。

K252282SurgiCount+ 系統Stryker Instruments K163507翠龍滲透系統Gauss Surgical, Inc.,K160338翠龍系統Gauss Surgical, Inc.,

官方來源

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