NEPHROSS I.Q. ANDANTE— 510(k) K874549

Name: FDA 510(k) clearance K874549
Creator: U.S. Food and Drug Administration
Published: 1988-01-29

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K874549 for NEPHROSS I.Q. ANDANTE, Substantially Equivalent on 1988-01-29. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1987-11-04
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.