Novy Cornual Cannulation Set

• • Terminated Z-2621-2016 FDA Class II ·initiated 15 Apr 2016

  Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

• 2 recalls, same reason

  • Terminated Z-1138-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2010
  • Terminated Z-1137-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2010

  The distal tip may separate from the catheter while the catheter is in the patient.

510(k) Number

K931476 ↗

FDA Product Code

MOV

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• Balloon Dilation Catheter

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• Laparoscopic Catherter

  Class II

  FDA 510(k) K903187 Active Cleared 12 Oct 1990

See all devices from Cook Ob/Gyn →