DISPOS. I/A & IRRIGATION HANDPIECES— 510(k) K833783

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K833783 for DISPOS. I/A & IRRIGATION HANDPIECES, Substantially Equivalent on 1984-03-05. Applicant: CooperVision, Inc..

Clearance details

Applicant: CooperVision, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1983-10-28
Decision date: 1984-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southampton, GB

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.