KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY— 510(k) K060339

Substantially Equivalent

Tyco Healthcare/Kendall

FDA 510(k) clearance K060339 for KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY, Substantially Equivalent on 2006-04-28. Applicant: Tyco Healthcare/Kendall.

Clearance details

Applicant: Tyco Healthcare/Kendall
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2006-02-10
Decision date: 2006-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

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Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.