GV3000 PHACOEMULSIFIER/FRAGMENTER— 510(k) K883097

Substantially Equivalent

D.O.R.C. Intl. B.V.

FDA 510(k) clearance K883097 for GV3000 PHACOEMULSIFIER/FRAGMENTER, Substantially Equivalent on 1988-12-06. Applicant: D.O.R.C. Intl. B.V..

Clearance details

Applicant: D.O.R.C. Intl. B.V.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1988-07-22
Decision date: 1988-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, 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.