(I) LV AND (II) HV SERIES CANNULA— 510(k) K871043

Name: FDA 510(k) clearance K871043
Creator: U.S. Food and Drug Administration
Published: 1987-04-23

Substantially Equivalent for Some Indications

Celebration Medical Products, Inc.

FDA 510(k) clearance K871043 for (I) LV AND (II) HV SERIES CANNULA, Substantially Equivalent for Some Indications on 1987-04-23. Applicant: Celebration Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Celebration Medical Products, Inc.
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-03-17
Decision date: 1987-04-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.