EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV— 510(k) K060563

Name: FDA 510(k) clearance K060563
Creator: U.S. Food and Drug Administration
Published: 2006-06-02

Substantially Equivalent

Pajunk GmbH

FDA 510(k) clearance K060563 for EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV, Substantially Equivalent on 2006-06-02. Applicant: Pajunk GmbH. Device class: 2.

Clearance details

Applicant: Pajunk GmbH
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 2006-02-08
Decision date: 2006-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geisingen, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.