SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT— 510(k) K113680

Name: FDA 510(k) clearance K113680
Creator: U.S. Food and Drug Administration
Published: 2011-12-29

Substantially Equivalent

Soma Access Systems, LLC

FDA 510(k) clearance K113680 for SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT, Substantially Equivalent on 2011-12-29. Applicant: Soma Access Systems, LLC. Device class: 2.

Clearance details

Applicant: Soma Access Systems, LLC
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2011-12-15
Decision date: 2011-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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K253452 — Accuro 3S2026-07-24
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K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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 →

Recalls naming K113680

K-number listed on FDA's recall record

Z-0215-2015 — AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.Class II·Terminated·Soma Access Systems LLC·20140324

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113680.

Data sourced from openFDA. This site is unofficial and independent of the FDA.