BENJAMIN ENVOY PHACO HANDPIECE— 510(k) K022833

Substantially Equivalent

Benjamin Biomedical, Inc.

FDA 510(k) clearance K022833 for BENJAMIN ENVOY PHACO HANDPIECE, Substantially Equivalent on 2002-09-09. Applicant: Benjamin Biomedical, Inc..

Clearance details

Applicant: Benjamin Biomedical, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2002-08-26
Decision date: 2002-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.