UltraDrape UGPIV Barrier and Securement (34-15)— 510(k) K233965

Substantially Equivalent

Parker Laboratories, Inc.

FDA 510(k) clearance K233965 for UltraDrape UGPIV Barrier and Securement (34-15), Substantially Equivalent on 2024-08-15. Applicant: Parker Laboratories, Inc..

Clearance details

Applicant: Parker Laboratories, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2023-12-15
Decision date: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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.