Exel Huber Needle

• • Terminated Z-0638-2010 FDA Unclassified (pre-2012) ·initiated 23 Dec 2009

  Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue

510(k) Number

K895769 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Exel Spinal Needles

  Class II

  FDA 510(k) K895771 Active Cleared 16 Feb 1990

• Exel Dental Needle

  Class I

  FDA 510(k) K861150 Active Cleared 11 Apr 1986

• Exel Huber Infusion Set Rotating Wing

  Class II

  FDA 510(k) K926119 Active Cleared 11 Aug 1993

• Exel Safelet Catheter

  Class II

  FDA 510(k) K895768 Active Cleared 16 Feb 1990

• Disposable Syringes and Hypodermic Needles

  Class II

  FDA 510(k) K861153 Active Cleared 23 Apr 1986

• Exel a-V Fistula Set

  Class II

  FDA 510(k) K903945 Active Cleared 20 Nov 1990

See all devices from Exel Intl. →