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

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.

Clearance details

Applicant: Pajunk GmbH
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2006-02-08
Decision date: 2006-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geisingen, DE

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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.