ENDOCATER— 510(k) K863393

Name: FDA 510(k) clearance K863393
Creator: U.S. Food and Drug Administration
Published: 1987-06-11

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K863393 for ENDOCATER, Substantially Equivalent on 1987-06-11. Applicant: The Hygenic Corp.. Device class: Unclassified.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 1986-09-03
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.