510(k) K080898 ยท GDW Staple, Implantable
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
| Applicant | Tyco Healthcare Group LP, North Haven CT, US |
| Decision | Substantially Equivalent, May 5, 2008 |
| Received | Mar 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Sep 21, 2012 | Covidien 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 |
GDW | None listed |
| Mar 19, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Feb 13, 2012 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
| Sep 8, 2011 | Covidien 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 |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.