UNIMAX VERESS NEEDLE— 510(k) K111441

Substantially Equivalent

Unimax Medical Systems, Inc.

FDA 510(k) clearance K111441 for UNIMAX VERESS NEEDLE, Substantially Equivalent on 2011-08-19. Applicant: Unimax Medical Systems, Inc..

Clearance details

Applicant: Unimax Medical Systems, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2011-05-24
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.