FDA 510(k)

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

Numéro K : K251807 · 2026-03-06

Date de décision2026-03-06

Code produitKGE

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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?

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

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.

Essais cliniques associés

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Autres dossiers indiquant Olympus Medical Systems Corp. en tant que demandeur

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Poignée actionnée à l'avant Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Poignée actionnée à l'avant Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Poignée actionnée à l'avant Type S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

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Dispositifs connexes (Code : KGE)

K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems Corporation K242857ClearHemograsperFinemedix Co., Ltd.K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation K210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd.

Source officielle

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