FDA 510(k)

Align® Cover and Pad Guidance Tool

N.º K: K260114 · 2026-09-24

SolicitanteCIVCO Medical Instruments Co., Inc.

Fecha de decisión2026-09-24

Código de productoITX

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Align® Cover and Pad Guidance Tool is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K260114. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Align® Cover and Pad Guidance Tool?

Align® Cover and Pad Guidance Tool is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K260114.

When did Align® Cover and Pad Guidance Tool receive FDA 510(k) clearance?

Align® Cover and Pad Guidance Tool received FDA 510(k) clearance on 2026-09-24, under 510(k) number K260114.

Who is the listed applicant for Align® Cover and Pad Guidance Tool?

The FDA 510(k) record lists CIVCO Medical Instruments Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Align® Cover and Pad Guidance Tool?

The FDA product code for Align® Cover and Pad Guidance Tool is ITX.

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Otros registros que enlistan a CIVCO Medical Instruments Co., Inc. como solicitante

K231783VitroPRO K222052VitroPRO K211270CIV-Clear cover K163313Reprocesador de Probe Transesofágica ASTRA, Reprocesador de Probe Vaginal/Rectal ASTRA VR K160806Verza Guidance System

Dispositivos relacionados (Código: ITX)

K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Kit de Guía de Aguja Accuro® 3SRivanna Medical, Inc.K250883PROBAS ULTRASONICAS UM-3R (UM-3R); PROBAS ULTRASONICAS UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

Fuente oficial

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