REDON SET— 510(k) K001716

Name: FDA 510(k) clearance K001716
Creator: U.S. Food and Drug Administration
Published: 2000-07-19

Substantially Equivalent

Pfm Produkte Fur Die Medizin AG

FDA 510(k) clearance K001716 for REDON SET, Substantially Equivalent on 2000-07-19. Applicant: Pfm Produkte Fur Die Medizin AG. Device class: 2.

Clearance details

Applicant: Pfm Produkte Fur Die Medizin AG
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2000-06-05
Decision date: 2000-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Margarita, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.