FDA 510(k)

Disposable Distal Attachment D-201-13404

N.º K: K260856 · 2026-08-27

SolicitanteOlympus Medical Systems Corporation

Fecha de decisión2026-08-27

Código de productoFDS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Distal Attachment D-201-13404 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 2026-08-27 under 510(k) number K260856. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Distal Attachment D-201-13404?

Disposable Distal Attachment D-201-13404 is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K260856.

When did Disposable Distal Attachment D-201-13404 receive FDA 510(k) clearance?

Disposable Distal Attachment D-201-13404 received FDA 510(k) clearance on 2026-08-27, under 510(k) number K260856.

Who is the listed applicant for Disposable Distal Attachment D-201-13404?

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 Distal Attachment D-201-13404?

The FDA product code for Disposable Distal Attachment D-201-13404 is FDS.

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Otros registros que enlistan a Olympus Medical Systems Corporation como solicitante

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500 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 K250993Single Use Cytology Brush V (BC-V600P-3010)

Ver todos los 36 dispositivos →

Dispositivos relacionados (Código: FDS)

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.