Atlas FDA

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

FDA 510(k) clearance K080898 · decided 2008-05-05

Clearance details

K-number
K080898
Device name
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
Applicant
Tyco Healthcare Group LP
Decision
Substantially Equivalent
Date received
2008-03-31
Decision date
2008-05-05
Days to decision
35 days
Clearance type
Traditional
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
North Haven, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET recall (Z-2432-2012)Covidien LP2012-09-21
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: recall (Z-2433-2012)Covidien LP2012-09-21
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET recall (Z-2434-2012)Covidien LP2012-09-21
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: recall (Z-2435-2012)Covidien LP2012-09-21
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6 recall (Z-2436-2012)Covidien LP2012-09-21
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: recall (Z-2437-2012)Covidien LP2012-09-21
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET recall (Z-2438-2012)Covidien LP2012-09-21
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: recall (Z-2439-2012)Covidien LP2012-09-21
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO recall (Z-1227-2012)Covidien LP2012-03-19
DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Univers recall (Z-0991-2012)Covidien LP2012-02-13
DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535A Product Usage: The ENDO GIA UN recall (Z-0992-2012)Covidien LP2012-02-13
DUET TRS 45 4.8MM STRAIGHT SULU Product Code: DUET4548 Product Usage: The ENDO GIA UNIVERS recall (Z-0993-2012)Covidien LP2012-02-13
DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO GIA UN recall (Z-0994-2012)Covidien LP2012-02-13
DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERS recall (Z-0995-2012)Covidien LP2012-02-13
DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035A Product Usage: The ENDO GIA UN recall (Z-0996-2012)Covidien LP2012-02-13
DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UN recall (Z-0998-2012)Covidien LP2012-02-13
DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implant recall (Z-3164-2011)Covidien LP2011-09-08
DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Imp recall (Z-3165-2011)Covidien LP2011-09-08
DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implant recall (Z-3166-2011)Covidien LP2011-09-08
DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Imp recall (Z-3167-2011)Covidien LP2011-09-08
DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implant recall (Z-3168-2011)Covidien LP2011-09-08
DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Imp recall (Z-3169-2011)Covidien LP2011-09-08
DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implant recall (Z-3170-2011)Covidien LP2011-09-08
DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Imp recall (Z-3171-2011)Covidien LP2011-09-08