FDA 510(k)

FUJIFILM Stiffening Wire Device (SW-2000)

N.º K: K251204 · 2025-09-26

SolicitanteFUJIFILM Healthcare Americas Corporation

Fecha de decisión2025-09-26

Código de productoFDA

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

FUJIFILM Stiffening Wire Device (SW-2000) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251204. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FUJIFILM Stiffening Wire Device (SW-2000)?

FUJIFILM Stiffening Wire Device (SW-2000) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K251204.

When did FUJIFILM Stiffening Wire Device (SW-2000) receive FDA 510(k) clearance?

FUJIFILM Stiffening Wire Device (SW-2000) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251204.

Who is the listed applicant for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA product code for FUJIFILM Stiffening Wire Device (SW-2000) is FDA.

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Otros registros que enlistan a FUJIFILM Healthcare Americas Corporation como solicitante

K261713Synapse PACS (7.6.0)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233629Sistema de RM de Lucent APERTO K233687ECHELON Synergy V10.0 K233583FCT iSTREAM Phase 1

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Dispositivos relacionados (Código: FDA)

K260314Ancora-SBAspero Medical, Inc.K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation K231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton K213195Balloon BS-3Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd.

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.