CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR— 510(k) K920114

Substantially Equivalent

Spiess Design, Inc.

FDA 510(k) clearance K920114 for CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR, Substantially Equivalent on 1992-04-06. Applicant: Spiess Design, Inc..

Clearance details

Applicant: Spiess Design, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1992-01-10
Decision date: 1992-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.