Cleared Special

K063071 - DISCYPHOR CATHETER SYSTEM, MODEL D01A

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

K063071 is an FDA 510(k) clearance for DISCYPHOR CATHETER SYSTEM, manufactured by Kyphon, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Special 510(k) pathway after a 189-day FDA review.

K063071 · Kyphon, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K063071

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Modification to existing cleared device.

BSP Device Classification - Class 2, Special Controls

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 129
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K063071.
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K063350 · PAJUNK GmbH Medizintechnologie · Feb 2008
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
K070354 · International Medical Development, Inc. · Oct 2007
ECHOSTIM FACET TIP
K063380 · Havel'S, Inc. · Apr 2007
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394 · Busse Hospital Disposables, Inc. · Sep 2006
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A
K061210 · Kyphon, Inc. · Jun 2006
RX EPIDURAL NEEDLE
K053318 · Epimed International, Inc. · Feb 2006