Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K073516 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B

  Class II

  FDA 510(k) K063071 Active Cleared 13 Apr 2007

• Kyphx Hv-R Bone Cement Model C01A

  Class II

  FDA 510(k) K041584 Active Cleared 7 Jul 2004

• Kyphon Inflatable Bone Tamp

  Class II

  FDA 510(k) K981251 Active Cleared 2 Jul 1998

• Kyphx Hv-R, Model C01A

  Class II

  FDA 510(k) K033801 Active Cleared 1 Apr 2004

• Kyphx Inflatable Bone Tamp, Size 20/3, Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A

  Class II

  FDA 510(k) K010246 Active Cleared 14 Feb 2001

• Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B

  Class II

  FDA 510(k) K061210 Active Cleared 27 Jun 2006

See all devices from Kyphon, Inc. →