ANIMUS EZSERTER INFUSION SET INSERTER— 510(k) K021700

Name: FDA 510(k) clearance K021700
Creator: U.S. Food and Drug Administration
Published: 2002-06-04

Substantially Equivalent

Animas Corp.

FDA 510(k) clearance K021700 for ANIMUS EZSERTER INFUSION SET INSERTER, Substantially Equivalent on 2002-06-04. Applicant: Animas Corp.. Device class: 2.

Clearance details

Applicant: Animas Corp.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 2002-05-23
Decision date: 2002-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frazer, PA, US

Download summary PDF View on FDA.gov ↗

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K042873 — ANIMAS MODEL IR1250 INSULIN INFUSION PUMP2004-12-10
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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.