LM-100/200LOW FLOW INSUFFLATOR— 510(k) K912789

Substantially Equivalent

Leisegang Medical, Inc.

FDA 510(k) clearance K912789 for LM-100/200LOW FLOW INSUFFLATOR, Substantially Equivalent on 1991-09-20. Applicant: Leisegang Medical, Inc..

Clearance details

Applicant: Leisegang Medical, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1991-06-25
Decision date: 1991-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.