One Step Button(Tm)

• • Terminated Z-0402-2016 FDA Class II ·initiated 11 Sep 2015

  Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

• 5 recalls, same reason

  • Terminated Z-0972-05 FDA Unclassified (pre-2012) ·initiated 2 Jun 2005
  • Terminated Z-0962-05 FDA Unclassified (pre-2012) ·initiated 2 Jun 2005
  • Terminated Z-0970-05 FDA Unclassified (pre-2012) ·initiated 2 Jun 2005
  • Terminated Z-0969-05 FDA Unclassified (pre-2012) ·initiated 2 Jun 2005
  • Terminated Z-0971-05 FDA Unclassified (pre-2012) ·initiated 2 Jun 2005

  Two blades may be heat staked onto the stiletto instead of the expected one blade.

510(k) Number

K910584 ↗

FDA Product Code

KGC

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gastrointestinal Tubes & Accessories

  Class II

  FDA 510(k) K945618 Active Cleared 12 Oct 1995

• Background Suction Matt

  Class I

  FDA 510(k) K895727 Active Cleared 24 Oct 1989

• Vessel Occluder

  Class I

  FDA 510(k) K895726 Active Cleared 24 Oct 1989

• Stoma Measuring Device

  Class II

  FDA 510(k) K923692 Active Cleared 7 May 1993

• Vessel Loops

  Class I

  FDA 510(k) K895682 Active Cleared 24 Oct 1989

• Pre-Loaded Replacement G-Tubes and Accessories

  Class II

  FDA 510(k) K972478 Active Cleared 9 Feb 1998

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