ASICO SOFTIP INJECTOR SYSTEM— 510(k) K103495

Name: FDA 510(k) clearance K103495
Creator: U.S. Food and Drug Administration
Published: 2011-06-29

Substantially Equivalent

Asico, LLC

FDA 510(k) clearance K103495 for ASICO SOFTIP INJECTOR SYSTEM, Substantially Equivalent on 2011-06-29. Applicant: Asico, LLC. Device class: 1.

Clearance details

Applicant: Asico, LLC
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2010-11-29
Decision date: 2011-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

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.