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

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.

Clearance details

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

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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 →

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