FDA 510(k)

一次性熱式組織切片镊子（FD-210U）；一次性熱式組織切片镊子（FD-230U）

K 號：K250187 · 2025-10-07

決定日期2025-10-07

產品代碼KGE

諮詢委員會GU

決定相當於

器材摘要

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K250187. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250187.

When did Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) receive FDA 510(k) clearance?

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K250187.

Who is the listed applicant for Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

FDA 510(k) 記錄中將Olympus Medical Systems Corporation列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

The FDA product code for Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is KGE.

其他以 Olympus Medical Systems Corporation 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。

K260824胃腸內視鏡奧林巴斯 GIF-2T1500 K260856一次性遠端附件 D-201-13404 K260401EVIS EUS 超聲波支氣管纖維內視鏡 OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS 超聲波胃腸內視鏡 (Olympus GF-UE190)K261260HD攝影鏡頭 OLYMPUS CH-S200-08-LB K252050一次性活體切片镊子 FB-211D, FB-221D, FB-231D, FB-241D

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相關器械（代碼：KGE）

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。

K251807單次使用電外科止血鉗 FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K242857清晰血漿吸取器Finemedix Co., Ltd.K231721一次性熱式組織切除镊Beijing Zksk Technology Co., Ltd.K220053電熱切刀（平刀）DK2620JI 及 DK2623JIFujifilm Corporation K210406雙極凝固鉗Hangzhou AGS MedTech Co., Ltd.K202438確保一次性凝血镊Micro-Tech (Nanjing) Co., Ltd.

官方來源

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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。