FDA 510(k)

再製EndoWrist Tenaculum 鐵鎚 (420207)

K 號：K250539 · 2025-08-19

決定日期2025-08-19

產品代碼QSM

諮詢委員會GU

決定相當於

器材摘要

Remanufactured EndoWrist Tenaculum Forceps (420207) is the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K250539. The device is classified under product code QSM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Remanufactured EndoWrist Tenaculum Forceps (420207)?

Remanufactured EndoWrist Tenaculum Forceps (420207) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Rebotix. The 510(k) number is K250539.

When did Remanufactured EndoWrist Tenaculum Forceps (420207) receive FDA 510(k) clearance?

Remanufactured EndoWrist Tenaculum Forceps (420207) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K250539.

Who is the listed applicant for Remanufactured EndoWrist Tenaculum Forceps (420207)?

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

What is the FDA product code for Remanufactured EndoWrist Tenaculum Forceps (420207)?

The FDA product code for Remanufactured EndoWrist Tenaculum Forceps (420207) is QSM.

其他以 Rebotix 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。

K250417再製EndoWrist Cobra抓取器（420190）K250399再製造EndoWrist Cadiere 鐵鍵 (420049)K250387再製造內視鏡手腕長針子彈針（420048）K241872再製造EndoWrist ProGrasp 鐵鎚 (420093)

相關器械（代碼：QSM）

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。

K252926機器人外科器械 - 永久灼術鉗 (470183)；機器人外科器械 - 永久灼術 spatula (470184)Restore Robotics K250417再製EndoWrist Cobra抓取器（420190）Rebotix K250399再製造EndoWrist Cadiere 鐵鍵 (420049)Rebotix K250387再製造內視鏡手腕長針子彈針（420048）Rebotix K2426108mm 单极弯曲剪刀 (470179)Iconocare Health K241872再製造EndoWrist ProGrasp 鐵鎚 (420093)Rebotix

官方來源

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