FDA 510(k)

單次使用電外科止血鉗 FD-410LR, FD-411UR, FD-412LR

K 號：K251807 · 2026-03-06

決定日期2026-03-06

產品代碼KGE

諮詢委員會GU

決定相當於

器材摘要

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K251807. 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 Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR?

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K251807.

When did Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR receive FDA 510(k) clearance?

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR received FDA 510(k) clearance on 2026-03-06, under 510(k) number K251807.

Who is the listed applicant for Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR?

FDA 510(k) 記錄將Olympus Medical Systems Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR?

The FDA product code for Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR is KGE.

其他以 Olympus Medical Systems Corp. 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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本 K254056THUNDERBEAT 5 mm, 45 cm, 前動握把型 S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前動握把型 S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前動握把型 S (TB-0520FCS)K260580單次使用可重裝夾釘應用器（HX-810LR，HX-810UR）；夾釘（HX-610-090，HX-610-135）；長夾釘（HX-610-090L，HX-610-135L）；短夾釘（HX-610-090S，HX-610-135S）；超短夾釘（HX-610-135XS）K252341EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-Q190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-H190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-1TH190)K253646單次使用遠端蓋 MAJ-2315 (MAJ-2315)K251336VISERA ELITE III 頻道系統中心 Olympus OTV-S700 (OTV-S700)；VISERA ELITE III 光源 Olympus CLL-S700 (CLL-S700)；4K 相機頭 Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

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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。

K250187一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）Olympus Medical Systems Corporation 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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