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FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE

FDA 510(k) clearance K043500 · decided 2005-04-15

Clearance details

K-number
K043500
Device name
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
Applicant
Innospine, Inc.
Decision
Substantially Equivalent
Date received
2004-12-20
Decision date
2005-04-15
Days to decision
116 days
Clearance type
Traditional
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Los Altos Hills, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc. recall (Z-0948-2008)Kyphon Inc2008-02-05