FDA 510(k)

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

Número K: K250187 · 2025-10-07

RequerenteOlympus Medical Systems Corporation

Data da decisão2025-10-07

Código do produtoKGE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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)?

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

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.

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Outros registros que listam Olympus Medical Systems Corporation como candidato(a)

K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Fonte oficial

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