PROCEDUR SF SAFETY SYRINGE DEVICE— 510(k) K042487

Substantially Equivalent

Avanca Medical Devices, Inc.

FDA 510(k) clearance K042487 for PROCEDUR SF SAFETY SYRINGE DEVICE, Substantially Equivalent on 2005-01-21. Applicant: Avanca Medical Devices, Inc..

Clearance details

Applicant: Avanca Medical Devices, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2004-09-13
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.