ClearanceBrief
510(k) K080898 ยท GDW Staple, Implantable

AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT

ApplicantTyco Healthcare Group LP, North Haven CT, US
DecisionSubstantially Equivalent, May 5, 2008
ReceivedMar 31, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080898

DateFirm and productCodeLinked 510(k)
Sep 21, 2012Covidien LP
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet T
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet
Terminated
GDWNone listed
Sep 21, 2012Covidien LP
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with
Terminated
GDWNone listed
Mar 19, 2012Covidien LP
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatri
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal, gynecologic and pediatric surgery fo
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic sur
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 45 4.8MM STRAIGHT SULU Product Code: DUET4548 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery f
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic su
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery f
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic sur
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic su
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appl
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4548 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appl
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4548A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appli
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appli
Terminated
GDWNone listed
Sep 8, 2011Covidien LP
DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.