INSITE MODEL 20 & MODEL 15 INSUFFLATORS— 510(k) K934926

Substantially Equivalent

Andronic Devices, Ltd.

FDA 510(k) clearance K934926 for INSITE MODEL 20 & MODEL 15 INSUFFLATORS, Substantially Equivalent on 1994-05-26. Applicant: Andronic Devices, Ltd..

Clearance details

Applicant: Andronic Devices, Ltd.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-10-14
Decision date: 1994-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, B.C. Canada V6v 2j2, CA

Download summary PDF View on FDA.gov ↗

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.