K922197

Substantially Equivalent

INSUFFLATOR TUBING KIT

Applicant: O.R. Concepts, Inc.
Product code: HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1992-05-11
Decision date: 1993-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, 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.