STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM— 510(k) K980488

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K980488 for STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM, Substantially Equivalent on 1998-03-23. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1998-02-09
Decision date: 1998-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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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.