FDA 510(k)

TroCare TroKit 腹腔鏡鏡頭擦拭器 (CP000626)

K 號：K241796 · 2024-10-04

決定日期2024-10-04

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

TroCare TroKit Laparoscope Lens Wiper (CP000626) is the device name listed in this FDA 510(k) record. The listed applicant is TroCare, LLC. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241796. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TroCare TroKit Laparoscope Lens Wiper (CP000626)?

TroCare TroKit Laparoscope Lens Wiper (CP000626) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is TroCare, LLC. The 510(k) number is K241796.

When did TroCare TroKit Laparoscope Lens Wiper (CP000626) receive FDA 510(k) clearance?

TroCare TroKit Laparoscope Lens Wiper (CP000626) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241796.

Who is the listed applicant for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

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

What is the FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

The FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626) is GCJ.

其他以 TroCare, 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。

K253994TroKit 腹腔鏡鏡頭擦拭器

相關器械（代碼：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE選擇系統Karl Storz SE & CO. KG K260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony Corporation K261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical Impact K261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。