STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)— 510(k) K961310

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K961310 for STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES), Substantially Equivalent on 1996-06-27. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1996-04-04
Decision date: 1996-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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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.