STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE— 510(k) K926512

Substantially Equivalent

Storz

FDA 510(k) clearance K926512 for STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE, Substantially Equivalent on 1993-09-09. Applicant: Storz.

Clearance details

Applicant: Storz
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1992-12-30
Decision date: 1993-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.