CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR— 510(k) K914101

Substantially Equivalent

Circon Video

FDA 510(k) clearance K914101 for CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR, Substantially Equivalent on 1991-11-22. Applicant: Circon Video.

Clearance details

Applicant: Circon Video
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1991-09-12
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stanford, CT, 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.