STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS— 510(k) K921460

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K921460 for STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS, Substantially Equivalent on 1992-07-02. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1992-03-27
Decision date: 1992-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.