Conmed Vcare Retractor/Elevator

• 3 recalls, same reason

  • Terminated Z-0178-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008 ·on shared 510(k) K955446
  • Terminated Z-0180-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008 ·on shared 510(k) K955446
  • Terminated Z-0179-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008 ·on shared 510(k) K955446

  The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K955446 ↗

FDA Product Code

LKF

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K934828 Active Cleared 7 Mar 1994

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  FDA 510(k) K983782 Active Cleared 25 Jan 1999

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• Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm

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  FDA 510(k) K963787 Active Cleared 11 Mar 1997

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