REFLEX INS INSUFFLATION NEEDLE— 510(k) K942207

Substantially Equivalent

Richard-Allan Medical

FDA 510(k) clearance K942207 for REFLEX INS INSUFFLATION NEEDLE, Substantially Equivalent on 1994-05-27. Applicant: Richard-Allan Medical.

Clearance details

Applicant: Richard-Allan Medical
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1994-05-05
Decision date: 1994-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, 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.