Cleared Special

DISCYPHOR CATHETER SYSTEM, MODEL D01A (K063071) - FDA 510(k) Clearance

Also marketed or referenced as:
DISCYPHOR INTRODUCER NEEDLE, MODEL D01B

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K063071 · Kyphon, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
189d
Days
Class 2
Risk

K063071 is an FDA 510(k) clearance for the DISCYPHOR CATHETER SYSTEM, MODEL D01A. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Kyphon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 2007 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kyphon, Inc. devices

Submission Details

510(k) Number K063071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2006
Decision Date April 13, 2007
Days to Decision 189 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 139d · This submission: 189d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 42
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K063071.
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PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · Baxter Healthcare Corp · Aug 1995
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · Sherwood Medical Co. · May 1995