Disposable Needle Guides and Grids— 510(k) K223689

Clearance details

Applicant

Advance Medical Designs, Inc.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2022-12-09

Decision date

2023-08-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marietta, GA, US

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel2017-10-25
• K053495 — EQUIPMENT SLUSH DRAPE2006-03-16
• K011265 — ULTRASOUND TRANSDUCER COVER2001-10-30
• K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH2001-09-18
• K011422 — SURGICAL DRAPES2001-07-10

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 →