Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)

• • Terminated Z-0393-2010 FDA Unclassified (pre-2012) ·initiated 23 Sep 2009

  Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

• 2 recalls, same reason

  • Terminated Z-0252-04 FDA Unclassified (pre-2012) ·initiated 20 Nov 2003 ·on shared 510(k) K032701
  • Terminated Z-0253-04 FDA Unclassified (pre-2012) ·initiated 20 Nov 2003 ·on shared 510(k) K032701

  improper staple formation or anvil jam

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

510(k) Number

K032701 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Idrives, Idrivec, Idrivef with Vascular Indications

  Class II

  FDA 510(k) K073148 Active Cleared 7 Dec 2007

• Power Circular Stapler Digital Loading Unit with and Without Sheath

  Class II

  FDA 510(k) K061649 Active Cleared 1 Sep 2006

• Surgassist Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units with Reloads

  Class II

  FDA 510(k) K030653 Active Cleared 31 Mar 2003

• Surgassist Straight Linear 4 Row No Knife Dlus with Reloads

  Class II

  FDA 510(k) K040398 Active Cleared 24 Mar 2004

• Surgassist System Straight Linear Cutter Digital Loading Unit, 55mm, 30mm with Blue and Green Reload Cartridges

  Class II

  FDA 510(k) K020719 Active Cleared 10 May 2002

• Surgassist Circular Stapler Digital Loading Units - 29 Mm, Model CS29

  Class II

  FDA 510(k) K040024 Active Cleared 4 Feb 2004

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