Intraoperative Ultrasound Probe Cover— 510(k) K222460

Substantially Equivalent

Exact Medical Manufacturing

FDA 510(k) clearance K222460 for Intraoperative Ultrasound Probe Cover, Substantially Equivalent on 2023-05-12. Applicant: Exact Medical Manufacturing.

Clearance details

Applicant: Exact Medical Manufacturing
Product code: Code ITX
Advisory panel: Radiology
Date received: 2022-08-15
Decision date: 2023-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou Jiangsu, CN

Download summary PDF View on FDA.gov ↗

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.