Phacoemulsification Needle (Tip) and Irrigation Sleeve— 510(k) K192418

Substantially Equivalent

Raico, LLC

FDA 510(k) clearance K192418 for Phacoemulsification Needle (Tip) and Irrigation Sleeve, Substantially Equivalent on 2020-05-27. Applicant: Raico, LLC.

Clearance details

Applicant: Raico, LLC
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2019-09-04
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.