DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR— 510(k) K073516

Substantially Equivalent

Kyphon, Inc.

FDA 510(k) clearance K073516 for DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR, Substantially Equivalent on 2008-02-21. Applicant: Kyphon, Inc..

Clearance details

Applicant: Kyphon, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2007-12-14
Decision date: 2008-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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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.