MECONIUM ASPIRATOR— 510(k) K893649

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K893649 for MECONIUM ASPIRATOR, Substantially Equivalent on 1989-08-21. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1989-05-15
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.