K043304

Substantially Equivalent

Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

Applicant: Bioject Medical Technologies, Inc.
Product code: LHI
Advisory panel: General Hospital
Date received: 2004-11-30
Decision date: 2005-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedminster, NJ, US

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.