JEJUNO-CATH KIT— 510(k) K905677

Name: FDA 510(k) clearance K905677
Creator: U.S. Food and Drug Administration
Published: 1991-08-09

Substantially Equivalent

Health Improvement Assoc.

FDA 510(k) clearance K905677 for JEJUNO-CATH KIT, Substantially Equivalent on 1991-08-09. Applicant: Health Improvement Assoc.. Device class: 2.

Clearance details

Applicant: Health Improvement Assoc.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-19
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeland, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.