STORZ DRAEGER ROTOR KERATOME— 510(k) K904845

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K904845 for STORZ DRAEGER ROTOR KERATOME, Substantially Equivalent on 1991-01-22. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1990-10-25
Decision date: 1991-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.