ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE— 510(k) K870775

Name: FDA 510(k) clearance K870775
Creator: U.S. Food and Drug Administration
Published: 1987-03-26

Substantially Equivalent

Entravision, Inc.

FDA 510(k) clearance K870775 for ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE, Substantially Equivalent on 1987-03-26. Applicant: Entravision, Inc.. Device class: 2.

Clearance details

Applicant: Entravision, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1987-02-26
Decision date: 1987-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenoir, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Entravision, Inc.

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K862063 — ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE1986-06-19
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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.