ECHOSTIM FACET TIP— 510(k) K063380

Name: FDA 510(k) clearance K063380
Creator: U.S. Food and Drug Administration
Published: 2007-04-25

Substantially Equivalent

Havel'S, Inc.

FDA 510(k) clearance K063380 for ECHOSTIM FACET TIP, Substantially Equivalent on 2007-04-25. Applicant: Havel'S, Inc.. Device class: 2.

Clearance details

Applicant: Havel'S, Inc.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2006-11-08
Decision date: 2007-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.