K892001

Substantially Equivalent

DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE

Applicant: Dexide, Inc.
Product code: HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1989-03-28
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.