FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A; INTRODUCER NEEDLE, MODEL D01B— 510(k) K061210
Substantially EquivalentKyphon, Inc.
FDA 510(k) clearance K061210 for FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A; INTRODUCER NEEDLE, MODEL D01B, Substantially Equivalent on 2006-06-27. Applicant: Kyphon, Inc.. Device class: 2.
Clearance details
- Device name as filed
- FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
- Applicant
- Kyphon, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code BSP
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- K041584 — KYPHX HV-R BONE CEMENT, MODEL C01A
- K033801 — KYPHX HV-R, MODEL C01A
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.