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FDA 510(k)

SmartGuide Disposable Guides and Grids

K-Number: K260161 · 2026-07-30

ApplicantUC-CARE , Ltd.
Decision Date2026-07-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartGuide Disposable Guides and Grids is the device name listed in this FDA 510(k) record. The listed applicant is UC-CARE , Ltd.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K260161. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartGuide Disposable Guides and Grids?

SmartGuide Disposable Guides and Grids is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is UC-CARE , Ltd.. The 510(k) number is K260161.

When did SmartGuide Disposable Guides and Grids receive FDA 510(k) clearance?

SmartGuide Disposable Guides and Grids received FDA 510(k) clearance on 2026-07-30, under 510(k) number K260161.

Who is the listed applicant for SmartGuide Disposable Guides and Grids?

The FDA 510(k) record lists UC-CARE , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartGuide Disposable Guides and Grids?

The FDA product code for SmartGuide Disposable Guides and Grids is ITX.

Other records listing UC-CARE , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250664Navigo Workstation 2.3 (FPRMC00039)K173054Navigo Workstation Version 2.0K160934UC-CARE NaviGo Workstation

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems CorporationK250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems CorporationK250524Mendaera Guidance SystemMendaera, Inc.K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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