RENEW NEUROSTIMULATION SYSTEM— 510(k) K000852

Name: FDA 510(k) clearance K000852
Creator: U.S. Food and Drug Administration
Published: 2001-01-19

Substantially Equivalent

Advanced Neuromodulation Systems

FDA 510(k) clearance K000852 for RENEW NEUROSTIMULATION SYSTEM, Substantially Equivalent on 2001-01-19. Applicant: Advanced Neuromodulation Systems. Device class: 2.

Clearance details

Applicant: Advanced Neuromodulation Systems
Product code: Code GZF
Device class: Class 2
Regulation: 21 CFR 882.5870
Advisory panel: Neurology
Date received: 2000-03-15
Decision date: 2001-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

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.