INSUFFLATION NEEDLE- 120MM, MODEL 900-200— 510(k) K993625

Substantially Equivalent

Genicon, LC

FDA 510(k) clearance K993625 for INSUFFLATION NEEDLE- 120MM, MODEL 900-200, Substantially Equivalent on 2000-06-20. Applicant: Genicon, LC.

Clearance details

Applicant: Genicon, LC
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1999-10-26
Decision date: 2000-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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.