ASEPTICO ENDOPEX V, MODEL AEU-40— 510(k) K030895

Substantially Equivalent

Aseptico, Inc.

FDA 510(k) clearance K030895 for ASEPTICO ENDOPEX V, MODEL AEU-40, Substantially Equivalent on 2003-12-03. Applicant: Aseptico, Inc..

Clearance details

Applicant: Aseptico, Inc.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2003-03-21
Decision date: 2003-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.