UNIMAX SUCTION IRRIGATION SET— 510(k) K103509

Substantially Equivalent

Unimax Medical Systems, Inc.

FDA 510(k) clearance K103509 for UNIMAX SUCTION IRRIGATION SET, Substantially Equivalent on 2011-05-19. Applicant: Unimax Medical Systems, Inc..

Clearance details

Applicant: Unimax Medical Systems, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-29
Decision date: 2011-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.