Solitaire

• 27 recalls, same reason

  • Terminated Z-2191-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2179-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2196-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2194-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2201-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2197-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2182-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2199-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2189-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2198-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2183-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2206-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2205-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2203-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2186-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2185-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2192-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2184-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2204-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2200-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2195-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2190-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2207-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2202-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2181-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2180-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101
  • Terminated Z-2193-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101

  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 ·on shared 510(k) K972101
  • Terminated Z-2187-2009 FDA Unclassified (pre-2012) ·initiated 4 Dec 2008 ·on shared 510(k) K972101

  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.

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

510(k) Number

K972101 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K884756 Active Cleared 13 Jan 1989

• Herador Ec, Pf, C, H, Nh, G, Gg and Mp; Heraloy U and G; Herabond N; Albabond C, B and a; Bio Heranorm

  Class II

  FDA 510(k) K034049 Active Cleared 1 Mar 2004

• Ames Dca 2000TM Analyzer and Reagent System

  Class II

  FDA 510(k) K911625 Active Cleared 5 Sep 1991

• Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)

  Class I

  FDA 510(k) K943780 Active Cleared 31 Oct 1994

• Flexitime Xtreme

  Class II

  FDA 510(k) K042878 Active Cleared 17 Dec 2004

• Venus Diamond Flow

  Class II

  FDA 510(k) K091635 Active Cleared 3 Sep 2009

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