HI-LINE MEDICAL PHACOEMULSIFIER TIP— 510(k) K952468

Substantially Equivalent

Hi-Line Medical

FDA 510(k) clearance K952468 for HI-LINE MEDICAL PHACOEMULSIFIER TIP, Substantially Equivalent on 1995-08-24. Applicant: Hi-Line Medical.

Clearance details

Applicant: Hi-Line Medical
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1995-05-26
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.