LATEX ULTRASONIC PROBE COVER— 510(k) K022156

Substantially Equivalent

Pleasure Latex Products Sdn. Bhd.

FDA 510(k) clearance K022156 for LATEX ULTRASONIC PROBE COVER, Substantially Equivalent on 2003-09-11. Applicant: Pleasure Latex Products Sdn. Bhd..

Clearance details

Applicant: Pleasure Latex Products Sdn. Bhd.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2002-07-02
Decision date: 2003-09-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Jeram, Selangor Darul Ehsan, MY

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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.