GYNESONICS EC6 TRANSDUCER— 510(k) K061153

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K061153 for GYNESONICS EC6 TRANSDUCER, Substantially Equivalent on 2006-10-27. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2006-04-26
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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Adverse events under product code ITX

product code ITX

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 →

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