INSUFFLATOR TUBING KIT— 510(k) K922197

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K922197 for INSUFFLATOR TUBING KIT, Substantially Equivalent on 1993-09-24. Applicant: O.R. Concepts, Inc..

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: 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

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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.