CATAREX VITRECUTTER I/A DISPOS. CUT— 510(k) K840063

Name: FDA 510(k) clearance K840063
Creator: U.S. Food and Drug Administration
Published: 1984-10-05

Substantially Equivalent

Calliope Corp.

FDA 510(k) clearance K840063 for CATAREX VITRECUTTER I/A DISPOS. CUT, Substantially Equivalent on 1984-10-05. Applicant: Calliope Corp.. Device class: 2.

Clearance details

Applicant: Calliope Corp.
Product code: Product code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 1984-01-09
Decision date: 1984-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Calliope Corp.

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K840181 — CATAREX/ULTRASONICS KIT1984-10-05
K832446 — CATAREX DIAP. EXTRACAPSULAR CATARACT1983-10-19

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.