STORZ E8010 ERGOTEC/PREMIERE ADAPTOR— 510(k) K964743

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K964743 for STORZ E8010 ERGOTEC/PREMIERE ADAPTOR, Substantially Equivalent on 1997-02-03. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1996-11-26
Decision date: 1997-02-03
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.