Entake Standard and Safety Peg System

• 26 recalls, same reason

  • Terminated Z-2191-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2196-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2194-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2201-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2197-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2182-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2199-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2189-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2198-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2183-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2206-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2205-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2203-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2186-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2185-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2192-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2184-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2204-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2200-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2195-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2190-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2207-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2202-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2181-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2180-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2193-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008

  Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

• 2 recalls, same reason

  • Terminated Z-2188-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008
  • Terminated Z-2187-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008

  The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

510(k) Number

K061021 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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