FDA 510(k)

Disposable Grasping Forceps FG-52D/FG-54D

N.º K: K250263 · 2025-03-31

SolicitanteOlympus Medical Systems Corp.

Fecha de decisión2025-03-31

Código de productoKTI

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Grasping Forceps FG-52D/FG-54D 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 2025-03-31 under 510(k) number K250263. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Grasping Forceps FG-52D/FG-54D?

Disposable Grasping Forceps FG-52D/FG-54D is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K250263.

When did Disposable Grasping Forceps FG-52D/FG-54D receive FDA 510(k) clearance?

Disposable Grasping Forceps FG-52D/FG-54D received FDA 510(k) clearance on 2025-03-31, under 510(k) number K250263.

Who is the listed applicant for Disposable Grasping Forceps FG-52D/FG-54D?

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 Disposable Grasping Forceps FG-52D/FG-54D?

The FDA product code for Disposable Grasping Forceps FG-52D/FG-54D is KTI.

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Otros registros que enlistan a Olympus Medical Systems Corp. como solicitante

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Sujeción Actuada en la Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Sujeción Actuada en la Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Sujeción Actuada en la Frente 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)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Fuente oficial

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