SmartGuide Disposable Guides and Grids— 510(k) K260161

Clearance details

Applicant

UC-CARE , Ltd.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2026-01-20

Decision date

2026-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Yokneam, IL

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24
• K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)2025-09-18

• K250664 — Navigo Workstation 2.3 (FPRMC00039)2025-08-07
• K173054 — Navigo Workstation Version 2.02018-01-16
• K160934 — UC-CARE NaviGo Workstation2017-02-06
• K100784 — UC-CARE NAVIGO SYTEM2011-11-01
• K090978 — UC-CARE WARMING SYSTEM2009-08-10

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →